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Finding
Value in
Digital Breast
29 Tomosynthesis
High-intensity Focused
Ultrasound | 18
Technology Report:
Enterprise Imaging | 22
COMPARISON CHARTS
Contrast Media Injectors | 3
Breast Tomosynthesis | 30
SBI/ACR Breast Imaging Symposium 2017 | April 6-9 | Los Angeles, Calif.
Scranton Gillette Communications
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COMPARISON CHART
Contrast Media Injectors
Advances in
Contrast Media Injector
Technology
By Jeff Zagoudis
W
ith medical imaging use on
the rise, contrast media use
is expected to grow as well,
according to a May 2016 report
from market research firm
GlobalData. According to the report, the global
market value for contrast injectors was $830 million
in 2015, and that number is expected to reach
nearly $1.8 billion by 2022 — an increase of nearly
$970 million in just seven years. The growth will
largely be driven by increasing use of computed
tomography (CT), magnetic resonance imaging (MRI)
and angiography procedures, as well as increasing
disease burdens, according to GlobalData.
In the United States, healthcare reform has
been another major driver of innovation. Reform
efforts such as the Medicare Access and CHIP
Reauthorization Act (MACRA) are poised to alter the
way clinicians are reimbursed, providing incentives
for them to practice more efficient, value-based
care and evaluating their performance based on the
quality of care delivered. In the world of contrast
injectors, this is spurring increased adoption of
technologies like syringeless injectors, which can
improve imaging exam efficiency, and contrast dose
recording systems, which can serve as a mechanism
for measuring quality of care.
Syringeless Injectors
meeting in November. The multi-dose delivery
system is designed for multi-patient use to increase
the number of scans clinicians can perform in a day.
The system is used in combination with the Isovue
Imaging Bulk Package (IBP) and saline (0.9 percent
sodium chloride injection USP). IBP was recently
defined by the United States Pharmacopeia as the
only contrast medium container for multi-dose,
multi-patient use directly in the radiology room.
Bracco’s other newest release, launched in
February, is SmartInjectCT, which packages the
EmpowerCTA+ contrast injection system with the
Nexo Contrast Dose monitoring solution. Empower
syringeless injectors are able to use every drop
of contrast loaded into the system for maximum
economy. These syringeless systems use a bulk 500
mL bolus, and the injectors meter out each dose as
needed. EmpowerCTA+ launched in March 2015 and
is indicated for the vascular administration of contrast
and flushing media in conjunction with CT scanning.
It allows users to fully customize the injection
experience for each patient with real-time variable
flow rates, saline advance and saline jump.
Guerbet launched its syringe-free injection
system, FlowSens, in March 2014. Composed of a
softbag injector and associated disposables, the
system uses a hydraulic, syringe-free injector to
deliver contrast media. It is compatible with the
company’s ScanBag solution and any type of contrast
agent available on the market.
Syringeless power injectors have emerged in recent
years as a solution to reduce contrast media waste.
The Joint Commission does not allow the reuse of
Dose Recording Systems
unused doses from single-use syringe injectors, so
While medical imaging and contrast use are on the
this option gives facilities the opportunity to use
rise, several recent studies have raised concerns
contrast media as efficiently as
about potential lingering effects of
possible. Syringeless injectors
contrast agents, particularly gadohave also been demonstrated
linium. As a result, several vendors
to reduce exam times, leading to
offer their own methods of recording
increased patient throughput. A
contrast dose and sending the inforBayer HealthCare
study published in the Journal of
mation directly to a picture archiving
www.healthcare.bayer.com
the American College of Radiology
and communication system (PACS),
in 2012 compared the efficiency
electronic medical record (EMR) or
Bracco
of a dual-syringe injector with
other data storage system.
www.bracco.com
a syringeless injector in 275
Bracco’s EmpowerCTA systems
consecutive CT exams. The
are supported by the Nexo Contrast
Guerbet
syringeless injector saved over
Dose monitoring solution, which
www.guerbet-us.com
2 minutes per exam, resulting in
automatically delivers all injection
an increased throughput of 2.6
information to a centralized server.
Nemoto
patients per day.1
This allows for enterprise-wide
www.nemotous.com
injector management. According
The first syringeless injector
to Bracco, Nexo has the ability to
on the U.S. market, Bracco’s CT
Scranton Gillette Communications
capture four Improvement activity
Exprès 3-D, launched at the
obtained the product specifications from
measures under the Merit-based
2016 Radiological Society of
the manufacturers.
Incentives Payment System (MIPS),
North America (RSNA) annual
Participants
3
March 2017 | itnonline.com | Imaging Technology News
one of the two new alternative reimbursement
tracks offered under MACRA.
Medrad most recently released version 2.5 of the
Radimetrics Enterprise Platform at RSNA 2014. The
latest release of Radimetrics features more advanced
contrast dose analytics, with new charts and data
options to help identify repeat injections and issues
associated with intravenous administration. The
platform is integrated onto several of Medrad’s
systems, including the MR Xperion.
Mallinckrodt launched its own contrast
dose monitoring solution, the OptiSync data
management system, in the fall of 2014 to
complement its OptiVantage dual-head CT contrast
delivery system. Operators can access all patient
and pharmaceutical information with the scan
of a barcode, and injection data — including
the patient, drug, dose and administration — is
transmitted to HL7-based healthcare systems while
patient records are automatically updated. This
creates a shared facility database that can help
users assess areas where they can reduce errors,
increase productivity or improve efficiency.
Other Recent System Releases
In February 2016, Guerbet announced U.S. Food
and Drug Administration (FDA) clearance for the
OptiOne single-head contrast delivery system.
OptiOne is manufactured by Liebel-Flarsheim, one
of the companies Guerbet acquired in November
2015 when it purchased Mallinckrodt’s Contrast
Media and Delivery Systems (CMDS) business. The
entry-level single-head injector is designed for
injection of radiopaque CT contrast agents into
the vascular system. It uses a motor-driven syringe
mechanism with microprocessor control of the flow
rate, volume, pressure and timing. All operations
are performed on the touch-screen console, and
the system has the ability to accommodate prefilled
or empty syringes. itn
Reference
1.
Ma, X., Singh, A., Fay, J., Boland, G., et al. “Comparison of Dual-Syringe
and Syringeless Power Injectors in Outpatient MDCT Practice:
Impact on the Operator’s Performance, CT Workflow, and Operation
Cost.” Journal of the American College of Radiology. Published
Aug. 2012.
Comparison chart compiled by
Imaging Technology News
Scranton Gillette Communications assumes
no responsibility or liability for any errors or
omissions in this chart.
COMPARISON CHART
Company name
4
Contrast Media Injectors
Bayer HealthCare
Bracco SpA
Product
Medrad Stellant Dual CT
Injection System w/ Certegra
Workstation
Medrad Stellant Dual CT
Injection System
Medrad MRXperion MR Injection System
Medrad Spectris Solaris EP
MR Injection System
Medrad Mark 7 Arterion
Injection System
EmpowerCTA+ Injector
System
CT Exprès 3D System
FDA cleared, year
Yes 2003 (Launched Certegra
Workstation 2012)
Yes, 2003
Yes 2015
Yes 2004
Yes 2011
Yes
Yes
CE mark, year
Yes
Yes
Yes
Yes
39233
Yes
Yes
Type (for which imaging modality)
CT
CT
MR
MR
Angiography
CT
CT
For cardiac imaging
Yes
Yes
Yes
Yes
Angiography
N/S
N/S
Other types of exams
N/A
N/A
N/A
N/A
N/A
N/S
N/S
For use in veins or
arteries
N/A
N/A
N/A
N/A
Both
N/S
N/S
Does system record
contrast dose used
Yes
No
Yes
No
Yes
Nexo provides patient past
records for better insights,
utilizing documentation
and referencing to ensure
accuracy
N/S
How does this data
interface with PACS,
CVIS or other reporting software
Yes
No
Yes
No
N/A
Multi-injector control with
seamless RIS/PACS connectivity for a smoother workflow
N/S
Other software
features
Certegra P3T 2.0 software
Certegra P3T 2.0 software
Onboard eGFR and weight
based dosing calculators. KVO
provides greater automation
of injection process
Independent KVO (keep vein
open) provides greater automation of injection process
Variable Flow software with
the Medrad VFlow Sterile
Hand Controller
Nexo provides protocol
management for centralized,
standardized quality and
compliance
N/S
What differentiates
your system from
other vendors
Scalable platform that is
able to be upgraded with
informatics technology
can automate data capture
and export to PACS, RIS, SR
systems; onsite field service
and remote support through
VirtualCare
Onsite field service as well
as remote support through
VirtualCare
Connection to the modality worklist; optional MR
Informatics connectivity
can automate data capture
and export to PACS, RIS, SR
systems; field service and
VirtualCare Remote Support
Onsite field service as well
as remote support through
VirtualCare Remote Support
Unique, front load syringe;
color, interactive user
interface; ergonomic design;
flexibility of multiple configurations
Nexo is a centralized, serverbased system for standardized contrast delivery
management
N/S
Number of syringes
2
2
2
2
1
2
N/A
Drive mechanism
Electromechanical
Electromechanical
Electromechanical
Electromechanical
Electromechanical
Electromechanical
Electromechanical
Syringe style
Two
Two
Two
Two
One
Yes
No
Syringe capacity, mL
200 contrast, 200 saline
200 contrast, 200 saline
65 contrast, 115 saline
65 contrast, 115 saline
150
2 - 200
N/A
Disposable
Yes
Yes
Yes
Yes
HPCT
Yes
Yes
Prefilled
No
No
No
No
No
No
No
Reusable
No
No
No
No
No
No
No
Flow range, mL/sec
0.1-10 mL/sec in 0.1 mL/sec
increments
0.1-10 mL/sec in 0.1 mL/sec
increments
0.01-3.1 in 0.01 mL/sec incre- 0.01-3.1 in 0.01 mL/sec incre- Fixed 0.1-45 mL/s
ments, 3.1-10 in 0.1 mL/sec
ments, 3.1-10 in 0.1 mL/sec
increments
increments
0.1-10, real time variable
flow rate control increases/
decreases flow rate based on
clinical need
0.5-9 mL/s (in steps of 0.1 mL/s),
max. flow rate depends on injected solution, prewarmed state
and needle size
User throughput
features
Auto fill/prime
Auto fill/prime
Auto fill/prime, eGFR calc.
N/A
Simple, color user interface
Protocol fill; auto purge;
arming at the injector; dual
initializing, simple and
intuitive user interface, saline
advance, saline jump, fill
rate, protocol storage, update
protocol library
No syringes for reduced filling and
cleanup; user-friendly interface
with dual touch screens; easily
switch between contrast bottles at
any point during the procedure
Volume range, mL
1 - 200,1 increments
1 - 200,1 increments
0.1 contrast, 1 saline
1 increments
1-150 in 1 increments
1 - 200 in user-specified
increments of 1
N/A
Delivery pressure
range, bar (psi)
50 - 325 psi max
50 - 325 psi max
100 - 325 psi
100 - 325 psi
100-1,200 psi in 1 psi increments
40-325
Syringeless 132
Pressure monitoring
Pressure monitored and
displayed on real-time pressure monitor graph during
injection
Pressure monitored and
displayed on real-time pressure monitor graph during
injection
Pressure monitored and
displayed on real-time pressure monitor graph during
injection
Pressure monitored and
displayed on workstation
during injection
Yes
Yes, with accessory tubing
that have one way valves
and large diameter tubing to
reduce pressure
Yes
Selectable pressure,
increments
50, 100, 150, 200, 250, 300,
325
50, 100, 150, 200, 250, 300,
325
100, 150, 200, 250, 300, 325
100, 150, 200
1mL increments
1
N/A
March 2017 | itnonline.com | Imaging Technology News
Comparison Chart Compiled by Imaging Technology News
Scranton Gillette Communications assumes no responsibility or liability for any errors or omissions in this chart.
Editor’s Note: Additional submitted information also appears on our website at www.ITNonline.com.
N/A = Not applicable N/S = Not specified
Guerbet
Nemoto Kyorindo Co., Ltd.
EmpowerMR Injector System
OptiVantage Dual-Head CT
Contrast Delivery System
with RFID
OptiStar Elite MR Contrast
Delivery System
Angiomat Illumena Contrast
Delivery System
OptiOne Single-Head Contrast OptiStat Hand-Held Contrast
Delivery System
Delivery System
Dual Shot Alpha 7
Rempress
Yes
Yes, 2007
Yes, 2008
Yes, 1997
Yes, 2016
Yes, 2002
K133189, 2014
K092896, October 2010
Yes
Yes, 2005
Yes, 2008
Yes, 1998
Yes, 2015
No
Yes, March 2013
Yes, April 2008
MRI
CT
MRI
Angiographic, CT
CT
CT
CT
Angio
N/S
N/S
N/S
N/S
N/S
N/S
Yes
Yes
N/S
N/S
N/S
N/S
N/S
N/S
Indicated for all CT examinations
Indicated for all angio
examinations
N/S
N/S
N/S
N/S
N/S
N/S
Veins
Arteries
N/S
No
No
No
No
No
The injector will maintain
a record of the last 100
injections
No
N/S
N/S
N/S
N/S
N/S
N/S
Not available in USA
N/A
N/S
N/S
N/S
N/S
N/S
N/S
MultiUser config, timing
bolus, NPT, SD card upgrades
Infusion mode, trace shot
mode, X-ray or inject delay
N/S
Prefilled contrast media
syringes, optional RFID and
OptiBolus bolus-shaping
software, fully programable
powerhead for scannerside operation, Patency
Check,Timing Bolus and CAN
interface
Built-in Patency Check
feature, auto home ram,
Timing Bolus feature, scanner
side operation
Cardio, angio and CT operating modes
Prefilled contrast
media syringes, OptiBolus
bolus-shaping software, fully
programable powerhead for
scanner-side operation, timing Bolus and CAN interface
Hand-held, portable injector,
includes remote control console, prefilled contrast media
syinges or empty syringes
and offers multiple mounting
options
Body weight protocol including heart mode, simplified syringes, ease of use, reliability
and only 2 component system
Compact size with small powerhead for easy maneurvering; designed specifically
for quick and easy operation
as required by the surgical
environment
2
2
2
1
1
1
2
1
Hydraulic
Electromechanical
Electromechanical
Electromechanical
Electromechanical
Electromechanical
Electromechanical
Electromechanical
Yes
Prefilled, prefilled w/RFID
and empty
Prefilled and empty
Prefilled and empty
Prefilled and empty
Prefilled and empty
Handheld style PET syringes
with patented safety notch
High pressure syringe
2 - 100 mL
A and B: 200
A and B: 60
150, 200
200
130
200 and 100
150
Yes
200 mL
60 mL
150 and 200 mL
200 mL
130 mL
Yes
Yes
No
50, 75, 100, 125; Saline: 125
10, 15, 20, 30; Saline: 50, 125
50, 75, 100, 125
50, 75, 100, 125
50, 75, 100, 125
Yes
No
No
N/A
N/A
N/A
N/A
N/A
No
No
0.1-10, real time variable
flow rate control increases/
decreases flow rate based on
clinical need
0.1 to 10
Side A: 60 mL syringe: 0.1 10 mL/s; 10, 15, 20 and 30
mL syringe: 0.1 - 8; Side B:
0.1 - 8mLs in increments of
0.1 mL
Angio: 0.1 - 40, CT :0.1 - 10
0.1 to 10
0.1 - 6 mL/sec
0.1 - 10
0.1 - 25
Auto-initialize and auto-fill
Compatible w/ Ultraject prefilled syringes; RFID captures,
stores and transmits data;
optional optibolus software
provides decelerating flow
rate for uniform enhancement; timing bolus, dual auto
fill; auto home after injection;
auto purge; patient volume
delivered indication
Compatible w/ Ultraject
prefilled syringes; auto retract
seq. for tech to remove both
syringes from powerhead w/
out waiting for both rams
to fully retract; when using
glass vials, tech fills syringes
outside of the magnet room;
Timing Bolus feature to inject
spec. amount of contrast
to determine the optimum
transit time of imaging agent
to ROI
Compatible w/ Ultraject
prefilled syringes; multimodality design allows the user
to switch between cardiac,
angio and CT modes with the
touch of 1 button
Compatible w/ Ultraject
prefilled syringes; Optional
Optibolus software provides
decelerating flow rate for uniform enhancement; Timing
Bolus, auto-fill, auto home
after injection; auto purge;
patient volume delivered
indication
Set and adjust flow rate and
volume, start/stop or pause
injection, scan delay and
elapsed timer
N/S
N/S
1 - 100 in 1 increment
1 mL to volume in syringe
1 mL to volume in syringe
1 mL to volume in syringe
1 mL to volume in syringe
1 mL to volume in syringe
1 ml up to syringe size
1 ml up to syringe size
40-300
25 nominal - 325 peak psi
10, 15, 20, 30, 50 mL prefilled
syringes at 200 psi; 60 mL
empty syringes at 150 psi;
125 mL prefilled at 100 psi
Angio 150 and prefilled
syringes: 75-1,200 psi; angio
200 mL syr: 75-900 psi; CT:
75-300 psi
25 nominal - 325 peak psi
50 - 270 peak psi
10 - 300
50 - 1,200
Yes, remote control
Yes, built in, user programmable pressure limit
Yes, built in, user programmable pressure limit
Yes, built in, user programmable pressure limit
Yes, built in, user programmable pressure limit
Yes, built in, user programmable pressure limit
Direct pressure sensor
monitor
Pressure is monitored via the
motor current
1
5 psi
10 psi
1 psi
5 psi
Automatic
10 psi increments
50 psi increments
Imaging Technology News | itnonline.com | March 2017
5
Delivery systems designed
the way you work.
Workflow efficiency
Control where you need it
Perform both single and dual syringe injections,
and save up to 40 four-phase protocols.
Minimize delays with console-enabled injector
controls and Auto Retract.
Get control where you need it with auto-fill,
tilt enable, CAN class 4 and relay interface
capabilities, and manual flow knobs calibrated
and color-coded for easy use.
Color touchscreen features intuitive
graphic design.
Help safeguard patients with Patency Check®
and Auto Purge features.
Battery-free operation and prefilled compatible.
Work efficiently with Timing Bolus® feature,
multi-phase protocol storage and Auto
Home feature.
For sales, service and support, contact your local sales representative or distributor.
Call 1.855.678.4250 or visit www.guerbet.com.
d to work
Simple. Flexible. Reliable.
Easy operation with auto-fill, Auto Purge
and Auto Home features.
Adapt to your workflow with multi-purpose
functionality, multi-phase programming
and multi-phase storage for up to 40 protocols.
Created for convenience and control, with
compact design, disposable or prefilled syringe
compatibility and Timing Bolus® feature.
The multi-modality injector
Gain flexibility to perform single- or multi-injection
procedures, switch operating modes with a single button,
and store and recall up to 45 user-defined protocols.
Support efficiency with LED display that automatically
flips as powerhead rotates, and fill control bar
featuring one-finger operation.
Console features easy tilt and rotation, and hand
and foot switches for comfortable system operation.
Optional Air Detection Aid & Warning System (ADAWS)
helps reduce the chance of injecting air into patient.
GU01171011
COMPARISON CHART
Company name
8
Contrast Media Injectors
Bayer HealthCare
Bracco SpA
Adjustable rise time
N/A
N/A
No
No
0.0-9.9 seconds in 0.1 mL
increments
Yes, the flow rate can ramp up No
or down during the injection
Adjustable volume
stop type
Electrical
Electrical
Electrical
Electrical
System adjustable by
operator
Automatic electronic
Automatic electronic
Increments
1 mL
1 mL
Contrast: 0.1 mL increments;
saline: 1 mL increments
Contrast: 0.1 mL increments;
saline: 1 mL increments
0.1 mL
1
0.1
Synchronization with
X-ray generator
Triggering interface with CT
scanner
Triggering interface with CT
scanner
N/A
N/A
Yes, ISI capability
Yes
Available April 2017
Console controls
Interactive, color touch screen Interactive, color touch screen Interactive, color touch screen Interactive, color touch screen Interactive, touch screen
Touchscreen at both injector
head in scan room and remote display in control room
Touchscreen at both injector head
in scan room and remote display in
control room
Synchronization with
ECG
N/A
N/A
No
No
N/A
No
No
Ceiling suspension
Yes
Yes
No
No
Yes
Yes
Yes
Suspension manufacturer
Mavig
Mavig
N/A
N/A
Mavig
N/S
N/S
Number of injector
head mounting
options
Three - ceiling, wall, pedestal
Three - ceiling, wall, pedestal
Pedestal with integrated
IV pole
Pedestal with integrated
IV pole
Three
Floor stand or ceiling
Floor stand or ceiling
Fully integrated, selfcontained unit
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Saline injection
capabilities
Yes, before and after contrast
Yes, before and after contrast
Yes, before and after contrast
Yes, before and after contrast
No
Yes
Yes
Air embolism detector FluiDots and air expelled
indicators
FluiDots and air expelled
indicators
Display on injector head
FluiDots and air expelled
indicators
No
No
Yes
Extravasation
detection
Yes,XDS extravasation
detector using RF wave
technology.; minimizing
extravasation techniques
coincide w/ACR guidelines
including saline test injection
and injection site monitoring;
on-site training provided by
registered radiologic technologist
Yes, XDS extravasation
detector using RF wave
technology.; minimizing
extravasation techniques
coincide w/ACR guidelines
including saline test injection
and injection site monitoring;
on-site training provided by
registered radiologic technologist
No
No
No
Optional
No
Operator alerts
Yes, armed indicator lights,
scan delay, inject delay and
injection complete tones
Yes, armed indicator lights,
scan delay, inject delay and
injection complete tones
Yes, armed, test injecton, scan Yes - armed, test injecton,
and inject delay, overpresscan and Inject delay, oversure, injection complete tones pressure, injection complete
tones
N/S
Voice prompts on remote,
confirm injection status
Remote and injector visual and audible alerts to facilitate immediate
response; also enhance workflow
and patient throughput
Overpressure
protection
Yes, pressure limit: user
selectable pressure limit;
overpressure alert message
Yes, pessure limit: user
selectable pressure limit;
overpressure alert message
Pressure limit setting control
with 6 factory presets from
100 - 325 PSI, overpressure
alert message
Pressure limit setting control
with 6 factory presets from
100 - 325 PSI, overpressure
alert message
Yes
Yes
Yes
Console size, H x W
x D, in.
13.5 x 15.8 x 10.2
13.5 x 15.8 x 10.2
13.46 x 15.75 x 10.23
10.9 x 11.9 x 10.5
12.62 x 11.042 x 3.040
17.8 x 33 x 71.1 (7 x 13 x 28)
11.8 x 7.9 x 8.7
Weight, lb.
17.6 workstation, 31.5 system 17.6 workstation, 31.5 system 19.2 workstation, 100.7
system and power supply
15 display, 60 system
146
8.2
10
Voltage, VAC
0.9 head only, 49.1 system,100-240
0.9 head only, 49.1 system,100-240
100-240, 50/60 Hz
100-240, 50/60 Hz
100-240, 50/60 Hz,
100-240
100-240
Warranty
1 year MFG Warranty, which
includes VirtualCare connection
1 year MFG Warranty, which
includes VirtualCare connection
1 year MFG Warranty, which
includes VirtualCare connection
1 year MFG Warranty, which
includes VirtualCare connection
1 year manufacturer warranty 1 year, optional 2, 3, 4 and
5 years
1 year, optional 2, 3, 4 and 5 years
Special features,
options, additional
product information
Informatics ready platform,
storage/recall of up to 250
protocols, Certegra P3T 2.0
Software, VirtualCare
Informatics ready platform,
storage/recall of up to 250
protocols, Certegra P3T 2.0
Software, VirtualCare
Informatics ready platform,
storage/recall of up to 60
protocols, VirtualCare remote
support
N/S
Arterion enables operator
to manage protocols, arm,
review injection history, set
options and view help topics
Reduces contrast media waste;
able to program, store protocols
with up to 8 phases; indicated for
use in CT procedures for the delivery of Isovue (Iopamidol Injection)
contrast media as supplied in
an Imaging Bulk Package (IBP),
for a maximum of 20 bottles of
contrast media or a maximum of
ten (10) hours, whichever comes
first, per Day Set III HP disposable;
the bottle spike disposable is for
single-bottle use only and must be
discarded with the contrast media
bottle; the patient set disposable
must be discarded after each
patient procedure
March 2017 | itnonline.com | Imaging Technology News
Saline advance pre-tests
injection site for vein patency
using saline prior to contrast
injection; tilt lock prevents
injection until head has
been tilted into run position;
fully compatible with Nexo;
server based decision support
system for patient care and
contrast management; allows
centralized contrast protocol
creation and implementation
from single location across
all networked injectors;
document contrast delivery
by patient, by room or by
department with key performance indicators; meets
requirements of BSI, CSA, IEC
60601-1, ISO 9000, and UL
2601-1
Comparison Chart Compiled by Imaging Technology News
Scranton Gillette Communications assumes no responsibility or liability for any errors or omissions in this chart.
Editor’s Note: Additional submitted information also appears on our website at www.ITNonline.com.
N/A = Not applicable N/S = Not specified
Guerbet
Nemoto Kyorindo Co., Ltd.
No
N/A
N/A
1-10 seconds
N/S
N/A
Selectable 0 sec or 2 sec
Setting from 0 to 9.9 sec
Automatic, servo-hydraulic
Automatic, electronic
Automatic, electronic
Automatic, electronic
Automatic, electronic
Automatic, electronic
Automatic electronic stop
Electronic and mechanical
stop
1
N/S
N/S
N/S
N/S
N/S
Automically controlled by
device
Automically controlled by
device
No
N/A
N/A
Yes
Yes
N/A
CAN Class 4
Logic interface
Injector and remote
N/S
N/S
N/S
Yes
Yes
Color LCD with touchscreen
GUI
Color LCD with touchscreen
GUI
No
N/A
N/A
Yes
N/A
N/A
No
No
No
Yes
No
Yes
Yes
N/A
Yes
Yes
N/S
Mavig
N/A
Mavig
Mavig
N/A
Mavig
Mavig
Floor
Rolling stand and ceiling
Rolling stand and mobile
coach floor / wall mount
Pedestal, ceiling, wall, table
and remote stand
Rolling stand and ceiling
Portable, wall, IV pole or CT
gantry
Pedestal and ceiling mount
Pedestal, ceiling and table
mount
Yes
No
No
Yes
No
Yes
No
Yes
Yes
Yes
Yes
Yes
No
No
Yes
No
No
No
No
Yes
No
No
Pressure limiting and graph
aide detection
Pressure limiting/graph aide
detection
No
Yes
Yes
No
No
No
Not available in USA
No
Voice prompts on remote,
confirm injection status
Yes
Yes
Yes
Yes
Yes
Various operator alerts are
provided to ensure proper
user interaction and settings
with the device
Various operator alerts are
provided to ensure proper
user interaction and settings
with the device
Yes
Yes
Yes
Yes.
Yes
Yes
Monitoring with pre-alert
messages and automatic stop
if pressure exceeded
Monitoring with pre-alert
messages and automatic stop
if pressure exceeded
27.9 x 33 x 10.2 (11 x 13 x 4)
12.3 x 8.5 x 2.5
12.3 x 8.5 x 2.5
12.3 x 8.5 x 2.5
12.3 x 8.5 x 2.5
6 W x 2 D x 1.8 H
4.2 x 10.6 x 9.8
8.3 x 9.6 x 3.5
4.5
5.8 (2.6)
5.8 (2.6)
5.8 (2.6)
5.8 (2.6)
0.3
59
147
100-240
100-120 or 220-240, 50-60
Hz
100-120 or 220-240, 50-60
Hz
110-120 or 220-240, 50-60
Hz
100-120 or 220-240, 50-60
Hz
Unit automatically adapts
for input voltages from 100
to 230
100 - 240/50/60 Hz
100 - 240/50/60 Hz
1 year, optional 2, 3, 4 and
5 years
1 year parts and labor, ex1 year parts and labor, ex1 year parts and labor, ex1 year parts and labor, ex1 year parts and labor
tended service plans available tended service plans available tended service plans available tended service plans available
Standard 2 years
Standard 2 years
Tilt lock prevents injection
until head has been tilted into
run position; hydraulic system
does not require batteries;
fully MR compatible up to
7T; connectivity to injector
reporting information system
(IRiS) contrast management
tool
Programmable powerhead
touchscreen; Patency Check
feature for extravasation prevention; setup for dual-head,
simultaneous or single-head
protocols; interface for CT;
optional optibolus bolus
shaping software; manufacturing ISO 13485, 2003 and
TUV certified; FDA cleared;
CE marked; UL, cUL and CSA
approved
Body weight protocol provided as a standard protocol
Footswitch option, table rail
mounting option
Battery-free power source,
Patency Check feature for
extravasation prevention;
status indicator line on
console, dual syringe w/
multiple user defined phases;
color coordinated push rods
and touchscreen; mftrg ISO
13485, 2003 and TUV certified; FDA cleared; CE marked;
UL, cUL and CSA approved
Versatile exam modes; switch
between cardiac, angio and
CT modes; ceiling, wall, pedestal or table mounts; accommodates Ultraject prefilled
syringes; ADAWS optional;
manufacturing ISO 13485,
2003 and TUV certified; FDA
cleared; CE marked. UL, cUL
and CSA approved; Japanese
Shonin approved
Capable of utilizing prefilled
or empty syringes, fully
programmable powerhead
touchscreen for scanner side
operation, optional OptiBolus
bolus-shaping software; FDA
cleared. CE marked; UL, cUL
and CSA approved
Capable of utilizing prefilled
or empty syringes; portable,
lightweight, durable design
Imaging Technology News | itnonline.com | March 2017
9
Work with quality,
in any application.
Our delivery systems are designed to work the way you do.
Our wide range of contrast delivery systems is built upon
UIFLFZWBMVFTPGRVBMJUZˍFYJCJMJUZFˎDJFODZBOETBGFUZ
FOTVSJOHUIBUNFEJDBMTUBˋBOEFRVJQNFOUXPSLUPHFUIFS
UPQSPWJEFFYDFMMFOUQBUJFOUDBSFJOBMMJNBHJOHNPEBMJUJFs.
Schedule your
in-person demo today.
Contact your representative to schedule your
free demonstration by calling 866-223-4434, or
visit www.Guerbet.com for more information.
Guerbet contrast delivery systems are all part of our Imaging Solutions & Services platform – a family
PGQSPEVDUTJOUFMMJHFOUMZBOEQVSQPTFGVMMZEFTJHOFEUPIFMQTUSFBNMJOFZPVSXPSLˍPXBOEPQUJNJ[F
DPOˌEF
NPEBMJUZ
0OMZ-JFCFM'MBSTIFJNEJTQPTBCMFTZSJOHFTBSFBVUIPSJ[FEGPSVTFXJUI-'JOKFDUPST These products are medical devices intended for use by medical imaging and diagnostic
health professionals. For complete information about precautions and optimal usage conditions, we recommend consulting the user's manual.
0QUJ7BOUBHF0QUJ4UBS&MJUF0QUJ0OF"OHJPNBU*MMVNJOB$MBTT**C3FBEZ#PY$MBTT**B$&.BOVGBDUVSFS-JFCFM'MBSTIFJN$PNQBOZ--$&BTU(BMCSBJUI3E
$JODJOOBUJ0IJP64"
GU07161054
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IMAGING
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16 | Imaging Technology Products
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The Technology Solutions Resource for Medical Imaging & Radiation Oncology Professionals | www.itnonline.com | March 2017
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About the cover
GE’s Senographe Pristina
3-D mammography platform
allows for excellent visualization of
breast lesions without increasing
the radiation dose compared to a
2-D mammography acquisition
of the same view.
Finding
Value in
Digital Breast
29 Tomosynthesis
High Intensity Focused
Ultrasound | 18
Technology Report:
Enterprise Imaging | 22
COMPARISON CHARTS
Contrast Media Injectors | 6
Breast Tomosynthesis | 30
SBI/ACR Breast Imaging Symposium 2017 | April 6-9 | Los Angeles, Calif.
PHOTO COURTESY OF GE HEALTHCARE
Scranton Gillette Communications
Imaging Technology News | itnonline.com | March 2017
11
from your editor
March 2017 | Vol. 57, No. 2
Melinda
Taschetta-Millane
Deep Learning in Medical Imaging
A
rtificial intelligence (AI), or deep learning, continues to be an
ongoing topic of conversation. According to a new report by
Signify Research, an independent supplier of market intelligence
and consultancy to the global healthcare information technology
industry, this will lead to a $300 million market by 2021.
The report stresses that in most
countries, there are not enough
radiologists to meet the ever-increasing
demand for medical imaging, and
many radiologists are already working
at full capacity. It’s likely the situation
will worsen as imaging volumes
increase faster than new radiologists
can enter the field.
A new breed of image analysis
software has emerged that uses deep learning
to help alleviate some of the more repetitive
and time-consuming tasks routinely performed
by radiologists. This growing array of products
automates the various stages of the imaging
diagnosis workflow.
“Radiology is evolving from a largely descriptive
field to a more quantitative discipline. Intelligent
software tools that combine quantitative
imaging and clinical workflow features will not
only enhance radiologist productivity, but also
improve diagnostic accuracy,” said Simon Harris,
principal analyst at Signify Research and author of
the report.
But it is still early in the game for deep
learning in medical imaging. Few products are
available, and it remains unclear how deep
learning will deal with multiple variations
in protocols and procedures. And, many
radiologists remain skeptical.
“Deep learning is a truly
transformative technology and the
longer-term impact on the radiology
market should not be underestimated.
It’s more a question of when, not if,
machine learning will be routinely used
in imaging diagnosis,” Harris concluded.
If you want to learn more about the
Signify Research study, visit http://bit.
ly/2lnCEau.
ITN a Neal Awards Finalist
Also, I’m proud to announce that ITN is again a
finalist in the prestigious Neal Awards editorial
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column on page 34 of this issue.) Now in its
63rd year, the Neal Awards recognize the best in
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Editorial Advisory Board
Paul J. Chang, M.D. | Prof. and Vice-Chairman Radiology Informatics,
Medical Director of Pathology Informatics, University of Chicago,
Pritzker School of Medicine; Medical Director of Enterprise Imaging,
University of Chicago Hospitals
Greg Rose, M.D., Ph.D. | Chief Medical Officer, Strategic Radiology
Katherine Andriole, Ph.D. | Center for Evidence-Based Imaging in the
Department of Radiology at Brigham and Women’s Hospital
Sam Friedman, M.D. | Nuclear Radiologist, Chief Technology Officer
Pitts Radiology, S.C.
Carter Newton, M.D., FACC | Asst. Prof. of Radiology,
Asst. Clinical Prof. of Cardiology, University of Arizona, Tucson
Vivek Mehta, M.D. | Radiation Oncologist, Director, Center for Advanced
Targeted Radiotherapies, Swedish Cancer Institute, Seattle, Wash.
Contributors
Infinium Global Research Team | Infinium Global Research
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News
Study Finds Medicare Imaging Utilization Highest
in First Half of Each Year
A
ccording to new research, Medicare imaging
utilization varies reasonably consistently on a
quarterly basis and is highest in the first half of the
year. The study, supported by research grants from
the Harvey L. Neiman Health Policy Institute, is published
online in the
Journal of the
American College
of Radiology
(JACR).
The
researchers
evaluated
associations
of an array of
patient factors
as well as withinyear temporal
variation on the
utilization of imaging in the Medicare population. Using
Centers for Medicare and Medicaid Services (CMS) data, they
identified imaging events nationally per 1,000 Medicare
beneficiaries from 2008 through 2014 on a quarterly basis.
“We observed that nationally, Medicare imaging utilization
increased 1.3 percent from 2008 to 2009 (3,496 to 3,542
imaging events per 1,000 beneficiaries), and then decreased
on average 1.2 percent annually to 3,331 events per 1,000
beneficiaries in 2014,” said Andrew Rosenkrantz, M.D., MPA,
an associate professor of radiology at NYU Langone Medical
Center and a Neiman Institute affiliate research fellow.
Rosenkrantz and his colleagues found that imaging
utilization events in the Medicare population varied
considerably based on patient comorbid conditions. They
also discovered that utilization was highest in those with
dual Medicaid eligibility and in those on Medicare due to
end-stage renal disease.
“Our findings indicate that a wide range of patient factors
— most outside of radiologists’ control — heavily influence
such variation. Thus, these factors will need to be properly
considered in order to reliably define the risk level of any
individual physician’s patient panel,” added Rosenkrantz.
“We believe that our observations have implications
regarding efforts under the Medicare Access and CHIP
Reauthorization Act to more precisely track utilization and
associated variation in utilization for individual physicians.
Such efforts will be important in creating metrics that
appropriately consider patient population complexity
and the impact of deductibles and co-pays on imaging
utilization,” noted Richard Duszak, M.D., FACR, professor and
vice chair for health policy and practice in the department
of radiology and imaging sciences at Emory University and
affiliate senior research fellow at the Neiman Institute. “As
radiologists embark on new payment models, within-year
temporal variation in imaging and specific features of
patient population attributed to their practices could have
important financial consequences.”
Briefs
• vRad Chief Medical Officer Joins
ACR Committee
vRad (Virtual Radiologic) announced that its Chief
Medical Officer Benjamin W. Strong, M.D., (ABR,
ABIM) recently received two American College of
Radiology (ACR) appointments due to his emergency
radiology expertise and long-term commitment to
the clinical practice of teleradiology.
• iCAD Appoints Executive Vice
President and CFO
iCAD announced that Richard C. Christopher has
been appointed executive vice president and chief
financial officer. He has more than 25 years of financial
management experience, having served as CFO of
two public companies with dermatology-related
businesses. Upon Christopher’s joining of the company,
interim chief financial officer R. Scott Areglado will
resume his role as vice president/corporate controller.
• RSNA Names New Editor
The Board of Directors of the Radiological Society
of North America (RSNA) announced that David
A. Bluemke, M.D., Ph.D., Ms.B., FAHA, FACR, will
become editor of the journal Radiology in January
2018. Bluemke is the radiologist-in-chief of
Radiology and Imaging Sciences at the National
Institutes of Health (NIH) Clinical Center and senior
investigator at the National Institute of Biomedical
Imaging and Bioengineering (NIBIB) in Bethesda,
Md. He also is adjunct investigator for the National
Heart, Lung and Blood Institute (NHLBI). Effective
July 1, 2017, he will become professor of radiology
in the Department of Radiology at the University of
Wisconsin – Madison School of Medicine and Public
Health (UW – Madison).
• ASTRO Supports Nominations
Astronauts’ Brains Change Shape During Spaceƪight
M
agnetic resonance imaging
(MRI) exams before and after
space missions reveal that astronauts’
brains compress and expand during
spaceflight, according to a University
of Michigan study.
The findings could have applications
for treating other health conditions
that affect brain function, said
principal investigator Rachael Seidler,
U-M professor of kinesiology and
psychology.
The study, believed to be the first
to examine structural changes that
take place in astronauts’ brains during
spaceflight, found that the volume of
gray matter increased or decreased,
and the extent of the alteration
depended on the length of time spent
in space.
Seidler and colleagues examined
structural MRIs in 12 astronauts who
spent two weeks as shuttle crew
members, and 14 who spent six
months on the International Space
Station. All experienced increases
and decreases in gray matter in
different parts of the brain, with more
pronounced changes the longer the
astronauts spent in space.
“We found large regions of gray
matter volume decreases, which
could be related to redistribution of
cerebrospinal fluid in space,” Seidler said.
“Gravity is not available to pull fluids
down in the body, resulting in so-called
puffy face in space. This may result in a
shift of brain position or compression.”
The researchers also found increases
in gray matter volume in regions that
control leg movement and process
sensory information from legs,
which may reflect changes related
to the brain learning how to move
in microgravity. These changes were
greater in space station astronauts
because their brains were learning and
adapting 24/7.
“It’s interesting because even if you
love something you won’t practice
more than an hour a day,” Seidler said.
But the brain changes researchers
observed were equivalent to someone
practicing a new skill round-the-clock.
“In space, it’s an extreme example
of neuroplasticity in the brain because
you’re in a microgravity environment
24 hours a day,” Seidler said.
Though they have not pinpointed
the exact nature of the changes yet,
the findings may lead to new ways
of thinking about certain health
conditions — for example, people on
long-duration bed rest or people who
have normal pressure hydrocephalus, a
condition in which cerebrospinal spinal
fluid accumulates in ventricles in the
brain and causes pressure.
Seidler said the brain changes
could reflect new connections
between neurons, and she’s leading
another long-term study that will
help determine the repercussions on
cognition and physical performance,
as well as how long the brain
changes last. For example, even after
balance returns, the brain might
still recruit different pathways to
compensate for the structural brain
changes caused by spaceflight.
“The behavior may return to normal,
but the way the brain controls the
behavior may change,” she said.
These results largely parallel
findings from a long-term bed rest
study that Seidler is leading, in which
volunteers spent up to three months
in a downward tilted position, and
brains shifted up.
The research is supported by a grant
from NASA. The study, “Brain structural
plasticity with spaceflight,” appeared in
the journal Nature Microgravity.
The American Society for Radiation Oncology (ASTRO)
expressed its support for the nominations of Tom Price,
M.D., as Health and Human Services (HHS) Department
secretary and Seema Verma as Centers for Medicare
and Medicaid Services (CMS) administrator.
• Hologic Board of Directors
Amy Wendell has been elected to Hologic’s Board
of Directors. Wendell also was appointed to the
company’s Audit and Finance Committee.
• ACR Confers Honors
The American College of Radiology (ACR) Board
of Chancellors (BOC) selected three innovators
as 2017 Gold Medalists for their extraordinary
service to the college or radiology. Honors will
be bestowed during ACR 2017 in Washington,
D.C.. The following individuals will receive the
ACR Gold Medal: Bruce J. Hillman, M.D., FACR,
of Wake Forest, N.C., professor of radiology and
medical imaging and health evaluation sciences
and former chair of radiology, University of
Virginia, and founding and current editor-inchief of the Journal of the American College of
Radiology (JACR); John A. Patti, M.D., FACR, of
Lynnfield, Mass., senior lecturer in radiology at
Harvard Medical School and thoracic radiologist
at Massachusetts General Hospital and Harvard
Medical School, both in Boston, and past chair
of the board and president of ACR; Jeffrey C.
Weinreb, M.D., FACR, of New Haven, Conn.,
professor of radiology and biomedical imaging
and vice chair for strategic planning and
innovation at Yale-New Haven Hospital/Yale
School of Medicine, and past BOC member and
vice-president of ACR.
Imaging Technology News | itnonline.com | March 2017
13
IMAGING
Global Trends
Global
IMAGING
A look into what will drive the medical imaging market’s future growth
By Infinium Global Research
T
he emerging markets of Asia-Pacific and Latin America will drive the medical imaging market by more than
5 percent by 2021. Globally, medical imaging has transformed the methods of diagnostics and has made the
diagnosis and treatment of several medical conditions more effective and efficient in the modern era. Growing
awareness about the usage of imaging devices for treatment in the healthcare segment and advancements in
technologies is driving the global market for medical imaging worldwide.
The global market for medical imaging was worth
$30.05 billion in 2015 and it is expected to reach
$40.56 billion in 2021, expanding at a compound
annual growth rate (CAGR) of 5.1 percent between
2016 and 2021. Medical imaging equipment can be
defined in many ways, but here is mainly categorized
as X-ray devices, computed tomography (CT)
scanners, magnetic resonance imaging (MRI) scanners,
ultrasound devices and nuclear imaging scanners.
X-ray Devices
X-ray devices currently dominate the medical
imaging market worldwide, while the nuclear
imaging market is anticipated to grow at the highest
CAGR by 2021.
A research report published by Infinium Global
Research1 found that X-ray devices dominated the
global medical imaging market, and are expected to
continue to do so with a market share of 29.36 percent
by 2021. The market size of X-ray devices is projected
to grow at a CAGR of 5 percent over the period of 2016
to 2021. X-ray imaging is the oldest form of medical
imaging, while it has evolved multifold in order to
make diagnosis and treatment more reliable. With
advancements in this segment, digital X-ray and 3-D
14
March 2017 | itnonline.com | Imaging Technology News
X-ray have become a trend in the recent
past. Moreover, advanced X-ray systems
help reduce the radiation dose.
Nuclear Imaging
With growing demand for radiation
devices for the treatment of various
types of cancers and neurological
medical conditions, the market size of
nuclear imaging is expected to grow
at the highest CAGR over the forecast
period. It is projected to grow at a CAGR
of 10 percent between 2016 and 2021.
Currently, with an increased number
of cancer patients, the demand for
Figure 1:
nuclear imaging devices is anticipated
Digital/synthetic reference object (DRO) analysis of the medical
to experience significant growth.
imaging market
Positron emission tomography (PET)
and single-photon emission computed
ultrasound imaging accounted for the second largest
tomography (SPECT) are nuclear imaging instruments
share — 21 percent — in 2015, while MRI accounted
used in nuclear imaging. Among the two, SPECT
for 19 percent share in the same year.
accounted for the largest segment in 2014 and 2015.
A growing geriatric population and rising number
Ultrasound
of cancer patients are likely to drive the global market
According to research conducted for the report,
of medical imaging, while high risk of radiation
TRENDS
26%
30.0%
32.5%
Figure 2:
Global Medical
Imaging market by
region, percentage
share (2015)
North America
7.5%
Latin America
Europe
Asia
ROW accounted for 4% in 2015
exposure is a primary restraining factor. The geriatric
population is exposed to a higher threat of cancer
and neurological disorders. Moreover, significant
environmental changes are likely to create more
health concerns for this segment of the population
worldwide. Further, technological advancements
in diagnostic imaging instruments are expected to
escalate the growth in this market by 2021.
as the U.S. and U.K. are anticipated to restrain the
growth in this market over the forecast period.
Asia-Pacific Market
The Asia-Pacific market is projected to grow at the
highest CAGR after dominating the global market
in 2015. The study estimated Asia-Pacific to be the
largest market for medical imaging instruments,
“The global market for medical imaging was
worth $30.05 billion in 2015 and it is expected
to reach $40.56 billion in 2021, expanding at a
CAGR of 5.1 percent between 2016 and 2021.”
One of the main risks associated with medical
imaging modalities is high risk of radiation exposure
associated with these devices, however it is also an
important factor affecting the growth in the medical
imaging market over the forecast period. (See Figure
1.) Additionally, stringent regulations pertaining to
use of radiation devices in developed markets such
with the growth in this market driven by emerging
markets such India and China, while Japan accounted
for the largest market share in the region in 2015.
(See Figure 2.) A large consumer base in this region
is the primary driving factor that is expected to
boost the growth over the forecast period. Emerging
markets such as India and China are projected to
experience significant growth over the forecast
period due to rapid infrastructure development in
the healthcare sector in these markets of Asia-Pacific.
North America, which was the second largest
market for medical imaging devices in 2015, is
currently dominated by the U.S. It is the largest
market for medical imaging devices among the
countries in the world market. Although the U.S.
market presents the most stringent laws pertaining
to usage of radiation devices, it also presents the
most technologically advanced medical imaging
modalities in the world. itn
Reference:
1. “Global Medical Imaging Market: Analysis, Trends and Forecast 2016
to 2021,” Infinium Global Research, http://www.researchandmar
kets.com/ Accessed Jan. 9, 2017.
Infinium Global Research is a business consulting and
market research firm; a group of experts who cater to
fulfilling business and market research needs of leading
companies in various industry verticals and business
segments. The company also serves government bodies,
institutes and non-profit/non-government organizations
to meet their knowledge and information needs.
Imaging Technology News | itnonline.com | March 2017
15
Imaging | PRODUCTS |
Musculoskeletal Ultrasound Education
Konica Minolta Healthcare Americas Inc. has partnered with 7Dimaging to strengthen its educational resources for
musculoskeletal ultrasound (MSK) by offering the mskNAV Education Tool. mskNAV is a portable and user-friendly,
tablet-based educational resource that assists users from beginner to advanced in enhancing their ultrasound
scanning skills in MSK procedures. The partnership allows Konica Minolta to distribute 7Dimaging’s mskNAV
interactive ultrasound training software with its portfolio of ultrasound products. The company will provide on-site
training and education in the area of MSK ultrasound, and the tool will complement the educational continuum
already offered by Konica Minolta for physicians to perform confident examinations and ultrasound-guided
injections.
Konica Minolta Healthcare | www.konicaminolta.com/medicalusa
Medical Imaging Consolidation
Hitachi Ltd. formed a
new Americas business
group focused on
consolidating its
various medical
imaging offerings while
expanding its focus on
healthcare innovation
and informatics.
The company will
combine Hitachi Aloka
Medical America Inc.
into Hitachi Medical
Systems America
Inc. on April 1, 2017,
which will then change
its name to Hitachi
Healthcare America
Corp. The newly
formed company
will function as the
regional headquarters,
providing sales and
maintenances services while driving an enhanced customer-focused strategy for growing the company’s
current medical modality segments. The company will also drive the expansion of its healthcare innovation and
strengthen its informatics-related medical businesses in the Americas. Hitachi also announced its intention to
integrate its Innovation and Informatics Division, which currently belongs to Hitachi America Ltd. into the new
Hitachi Healthcare America Corp. The company will focus on collaborative creation with its Americas-based
key partners and customers to realize advanced medical technology and informatics solutions, such as using
radiation therapy treatment data and artificial intelligence to support creating better treatment plans.
Hitachi Healthcare America Corp. | www.hitachimed.com
Iradimed Corp. received U.S. Food and Drug
Administration (FDA) 510(k) clearance for its
MRidium 3860+ magnetic resonance imaging
(MRI)-compatible IV infusion pump system,
including its Dose Error Reduction System
(DERS) software feature. The MRidium 3860+
MRI-compatible IV infusion pump system provides
a seamless approach that enables accurate, safe
and dependable fluid delivery before, during and
after an MRI scan. This is important to critically
ill patients who cannot be removed from their
vital medications, and children and infants who
must generally be sedated in order to remain
immobile during an MRI scan. The MRidium 3860+
system has been designed with a non-magnetic
motor, uniquely designed non-ferrous parts
and other special features in order to safely and
predictably deliver anesthesia and other IV fluids
during various MRI procedures. The system can
operate dependably in the presence of 0.2T to 3T
magnets and is fully operational up to the 10,000
gauss-line. This means it is highly versatile and
can operate virtually anywhere in the MRI scanner
room, including close to the MRI scanner.
Iradimed Corp. | www.iradimed.com
App-Based, Pocket-Sized
Dual-Probe Ultrasound
Siemens Healthineers and Biogen will jointly
develop magnetic resonance imaging (MRI)
applications with the intent of quantifying key
markers of multiple sclerosis (MS) disease activity
and progression. Biogen is a biotechnology
company with a deep focus on neurological and
autoimmune conditions. To execute this strategy
in the field of neurology, Siemens Healthineers
will cooperate with Biogen and contribute its
strength in medical imaging. MRI is routinely
used to support physicians in diagnosing MS,
measuring disease activity and monitoring
response to therapy. Clinicians qualitatively
evaluate MRIs by comparing the current MRI
to the previous MRI. Numerous studies have
demonstrated that quantitative MRI measures
may provide additional information about disease prognosis and therapeutic effect, but today quantitative
measurement techniques with the precision and sensitivity required for MS are typically only available in the
research setting. With the development and validation of automated MRI applications to quantify key markers
of MS, including new T2 lesions and brain atrophy, patients could benefit from the availability of enhanced data
at the point of care.
Vscan Extend from
GE Healthcare is a
new generation of
pocket-sized, dualprobe ultrasound.
From the hospital
and ambulance to
more rural environments, Vscan Extend uses high
image quality and wireless connectivity to help
users increase clinical confidence and improve
patient care. Vscan Extend offers an intuitive touch
screen and weighs just 406 grams. The system
offers smooth integration with hospitals’ DICOM
systems to complement existing documentation
and reporting solutions along with cloud-based
image storage and communication. Vscan
Extend is GE Healthcare’s first ultrasound system
to leverage the GE Marketplace that offers
applications with a range of capabilities, such
as assessing heart failure patients, measuring
bladder volume and offering cloud-based image
communication. The system comes with high-level
data security standards, ensuring encrypted data
both at rest and on the move.
Siemens Healthineers | www.usa.siemens.com/healthcare
GE Healthcare | www.gehealthcare.com
MRI Tools for Multiple Sclerosis
16
MRI-compatible IV
Infusion Pump
March 2017 | itnonline.com | Imaging Technology News
Samsungmedicalsolution.com
RADIATION ONCOLOGY
Focused Ultrasound Therapy
High-intensity
Oơers New
The emerging technology of focused ultrasound expands into many
treatment areas as a noninvasive alternative to surgery, radiation
therapy or chemotherapy
By Dave Fornell
F
ocused ultrasound (FUS), also called high-intensity focused ultrasound
(HIFU), has gained a lot of interest in recent years as noninvasive cancer
therapy that does not require radiation, chemotherapy or surgery,
resulting in less collateral damage to the patient. FUS is performed as
an outpatient procedure, so it can eliminate the usual two weeks of
recovery needed from most types of surgery.
In the U.S., the U.S. Food and Drug Administration
(FDA) has cleared FUS to treat bone metastases,
uterine fibroids, prostate cancer, benign prostatic
hyperplasia and essential tremor. Only bone
metastases currently has reimbursement. Outside
the U.S., there are additional regulatory approvals
for breast cancer, kidney cancer, liver cancer,
pancreatic cancer, soft tissue tumors, Parkinson’s
disease, thyroid nodules, back pain, osteoid osteoma,
Brain FUS uses
an array of about
1,000 elements
designed to overcome attenuation
issues presented
by the skull and to
diffuse the heating
over a large area
of the brain to
prevent damaging
healthly tissue.
PHOTO COURTESY OF GE HEALTHCARE
18
breast fibroadenomas, uterine adenomyosis and
neuropathic pain.1
Currently, use of FUS is generally considered
only if it will have a greater impact on the patient
than surgical outcomes, said Pejman Ghanouni,
M.D., Ph.D., assistant professor of radiology at the
Stanford University Medical Center. He is an expert
in FUS and involved in research for the use of FUS
in the treatment of various conditions, including
March 2017 | itnonline.com | Imaging Technology News
essential tremors, soft tissue tumors and localized
low-intermediate risk prostate cancer. He spoke on
the topic at sessions at the Radiological Society of
North America (RSNA) 2016 annual meeting.
As more providers begin offering FUS treatment
programs, Ghanouni said it is important to have a
radiologist champion the project. Patient recruitment
from referrals also needs to be considered, so it
is important to build relationships with referring
physicians. For example, at Stanford he said they
have a fibroid center, and one in 10 of the patients
with uterine fibroids will qualify for FUS treatment. He
said this is how his center primed the pump for initial
referrals. He also now works with Stanford’s prostate
cancer center, radiation therapy and desmoid tumor
clinic. He said one of the keys to finding patients has
been defining unmet needs and defining how FUS
can serve as a niche treatment option.
The Basics of High-intensity Focused
Ultrasound
According to the Focused Ultrasound Foundation,
the principle of FUS is analogous to using a
magnifying glass to focus beams of sunlight on a
single point to burn a hole in a leaf. With focused
ultrasound, an acoustic lens is used to concentrate
multiple intersecting beams of ultrasound on a target
deep in the body with extreme precision. Depending
on the design of the lens and the ultrasound
parameters, the target can be as small as 1 x 1.5 mm
or as large as 10 x 16 mm in diameter. Where each
of the individual beams passes through the tissue,
there is no effect. But, at the focal point where these
multiple beams converge, the focused ultrasound
energy results in tissue ablation.2
FUS uses thermal ablation to denature proteins
and cause cell death. The thermal dose required
to produce irreversible damage and coagulative
necrosis depends on the cell type, temperature
Focused Ultrasound
Opportunities
and duration of exposure. This ranges from one second at
130°F, to 240 seconds at 107°F. FUS also uses mechanical
tissue destruction to disrupt cells through cavitation, in which
bubbles of gas oscillate in an ultrasonic field and collapse,
which can generate enough force to allow for the targeted
destruction of tissue.3
FUS works in conjunction with magnetic resonance imaging
(MRI), which is used to identify and target tissue to be treated,
for real-time image guidance and control during treatment,
and to confirm the effectiveness of the therapy. MRI is used
to create a treatment plan similar to radiation therapy. A postprocedure MRI also is performed to confirm the effectiveness
FUS of Uterine Fibroids, Avoiding Complications
MRI anatomical assessment is used at the start of patient
evaluation to determine if the target is reachable by FUS,
said Young-Sun Kim, M.D., assistant professor, Department of
Radiology and Center for Imaging Science, Samsung Medical
Center, Seoul, South Korea. He is an expert in FUS and spoke at
RSNA 2016 sessions. In the case of uterine fibroids, he showed
an example where the treatment window to access the fibroid
might be blocked by cysts in the path of the ultrasound beam.
He said thick subcutaneous fat is another ultrasound beam
attenuation factor. Edema caused by fluid back up in a fibroid
may also lead to poor outcomes with FUS. He also suggests
avoiding resistant fibroids.
Additionally, Kim said radiologists
need to assess MR imaging along the
planned trajectory of the beams to
look for foreign bodies, which often
present as surgical procedure leftovers
like staples. He said these could
superheat during the procedure and
injure the patient.
MRI offers real-time thermography
during the FUS treatment, to ensure
healthy tissue is not damaged. Kim
said complications from FUS could
include skin burns, fat burns, sciatic
nerve injury and bowel injury. Like radiation therapy, Kim said
the focused ultrasound beams also could cause damage to
critical structures, such as nerves and the spine. This is why he
suggests using conscious sedation with IV fentanyl so patients
can offer feedback during the procedure.
Critical structures like the bowel and spine can often be
avoided by manipulating the bladder or bowel. Kim said this can
be done by filling or emptying the bladder, or filling the bowel
with ultrasound gel to move the bowel out of the way, or to
eliminate bowel loops.
“The U.S. Food and Drug Administration (FDA)
has cleared FUS to treat bone metastases,
uterine fibroids, prostate cancer, benign prostatic
hyperplasia and essential tremor. Only bone
metastases currently has reimbursement.”
of the treatment. For this reason, hospitals interested in
creating FUS programs need staff that is comfortable working
in the MRI suite. The close integration with MRI often has lead
to the therapy being referred to as magnetic resonance-guided
focused ultrasound (MRgFUS).
The treatment plan for FUS uses the anatomical MR imaging
with an overlay of the zones of treatment. These are shown
as strips, each representing a pass of the FUS beam. These
strips are usually stacked on top of each other and the length
of each varies to match the contours of the tumor target.
Operators need to watch the real-time MR imaging for the
formation of bubbles in the tissue being ablated, which can
deflect the FUS beams.
Treatment of Bone Tumors, Metastasis
As tumors grow inside bones, they slowly destroy and
Imaging Technology News | itnonline.com | March 2017
19
RADIATION ONCOLOGY
Focused Ultrasound Therapy
with the use of microbubbles. Early studies show this
breakdown of the barrier only lasts a couple hours
before it disappears.
HIFU to Treat Prostate Cancer
An example of pre- and post-treatment MRIs showing the effectiveness of HIFU therapy on breast cancer.
break apart the bone as the tumor expands.
With osteoid osteoma (benign bone tumors),
HIFU could both reduce the pain and stop the
tumor growth. However, with bone metastasis it
is best to limit treatment to the palliation of pain,
said Alessandro Napoli, M.D., Ph.D., Department
of Radiological and Oncological Sciences,
Sapiens University, Rome, who spoke on FUS at
RSNA 2016.
“It is totally noninvasive, there is no radiation and
we have low complication rates compared to other
therapies. This is because it is totally image guided,”
Napoli explained. “The quality of life is improved
greatly with the reduction of pain.”
During the procedure, he uses an epidural
nerve block or deep sedation because of the pain
involved in the procedure. His center also uses
gel pads to act as a coupler between the FUS and
the body. He uses perfusion MRI with contrast
both before and after procedures so he can see
reductions in tumor vascularity.
Napoli said FUS beams can be directed through
nerves if the beam is wide to reduce damage. The
bone also absorbs a lot of the FUS so the treatment
time will depend on the density of the bone and
amount of bone that needs to be penetrated.
FUS does not hamper the bone growth, which
Napoli said has been proven in several studies.
Imaging from these studies has shown new bone
growth months or years later with restored bone.
(Editor’s note: See the article “Researchers Investigate
Using Focused Ultrasound To Take Away Cancer Pain”
at http://bit.ly/2l53TU5.)
FUS of the Brain
A growing area of HIFU is in treatment of essential
tremor by applying FUS for thalamic ablations. In this
application, a special spherical FUS transducer system
has been developed that fits over the patient’s head.
Ghanouni showed before and after videos of patients
he treated who could not hold a glass of water
without spilling it, or use a spoon. After treatment
they were able to drink from the glass or use the
spoon normally. (Editor’s note: Read the article “FDA
Approves First MRI-guided Focused Ultrasound Device
to Treat Essential Tremor” at http://bit.ly/2l1sOer.)
20
March 2017 | itnonline.com | Imaging Technology News
Brain FUS uses an array of about 1,000 elements
designed to overcome attenuation issues presented
by the skull and to diffuse the heating over a large
area of the brain to prevent damaging healthly tissue.
“Bone is very efficient at absorbing ultrasound
energy,” Ghanouni said, explaining why so many
ultrasound elements are needed to treat the brain
and avoid overheating. Additionally, a silicon pad
surrounding the head that circulates chilled water is
used to transfer the ultrasound beams into the skull
and to cool the skin and head surface. Peri-procedural
MR thermography is used to monitor temperatures
and ensure areas outside of the target are not being
heated. The patient’s head also is shaved to permit the
transference of ultrasound waves.
In the case of the brain, he said computed
tomography (CT) is used for registration in the
treatment planning system. Planning includes
avoiding any calcifications inside the brain, because
they will heat up during treatment, Ghanouni
said. The procedure is performed with conscious
sedation so the patient can offer intraoperative
physiologic feedback. When the operators isolate
the target area, they first perform sublethal
sonifications to confirm their positioning before
delivering lethal sonifications.
These brain ablations can cause edema, but
Ghanouni said this usually resolves over time, and
as they reduce in size, there usually is dramatic
improvement in the patients. “The first week is not
representative of what the final result will be,” he
explained, adding there can be some bad side effects,
but these often resolve or change after about three
months. “The final result is often not seen until after
the three-month recovery period, so patients need
to be told this upfront. What they have after three
months is usually what they will keep.”
He said the FDA recently approved FUS for
essential tremor and there is an expectation that
CMS may begin reimbursing for the FUS sometime
in 2017. Ghanouni said a next step will be FUS
treatment of Parkinson’s disease, which is already an
approved indication overseas.
Another use of FUS in the brain may be to improve
targeted drug delivery to specific tumors. Ghanouni
said FUS can help break down the blood-brain barrier
Napoli said HIFU can be used as a primary treatment
for prostate cancer, or as a salvage treatment when
there is recurrence after surgery or radiation therapy.
He said it is important to target the individual lesions,
not to use FUS for whole gland treatment, which can
lead to urinary incontinence and erectile dysfunction.
He said a special FUS transrectal transducer has
been created so it can be placed against the rectal
wall, next to the prostate. This helps focus on the
prostate without worry of causing collateral damage
to surrounding critical structures.
“The primary argument against targeted treatment
for the prostate is that the disease is multifocal,”
Napoli explained. He said this often requires the
excision of the whole gland. “However, in most cases,
a single index or dominant lesion drives prostate
cancer risk. The optimal candidates for targeted
ablation need to be clearly identified.”
Unlike surgery or brachytherapy, HIFU is
significantly less invasive, which may be much more
appealing to patients. “It does not require incisions
or punctures, it is bloodless, can be carried out on
an outpatient basis, and it is repeatable,” Napoli said.
(Editor’s note: For more information, see the article
“Leading HIFU Expert Begins U.S.-Based Program
with Treatment of First Prostate Cancer Patients” at
http://bit.ly/2kzbp9V.)
Future Directions for HIFU
The use of FUS is still relatively new, and there are
many preclinical and early stage pilot clinical programs
investigating its expanded use for other conditions.
Expansion in oncology may include several new
cancers in the coming years. Pilot trials have started for
pediatric neuroblastoma, melanoma, brain, head and
neck, lung, ovarian and cervical cancers.
In neurology there are pilot clinical studies
for brain tumors, depression and obsessivecompulsive disorder (OCD). Preclinical studies
are underway for Alzheimer’s disease, epilepsy,
multiple sclerosis, stroke, traumatic brain injury
and trigeminal neuralgia. (Editor’s note: For more
information, see the article “Pre-Clinical Research
Validates Potential for Focused Ultrasound in
Alzheimer’s” at http://bit.ly/2kJYXGo.)
In cardiovascular medicine, there are pilot trials
testing FUS to treat hypertension. There also are
numerous preclinical studies looking at the use
of FUS to treat arteriovenous malformations,
atherosclerosis, atrial fibrillation, deep vein
thrombosis, heart block, peripheral artery disease
(PAD), septal perforation and heart failure. itn
References:
1. Focused Ultrasound Foundation. “Diseases and Conditions.”
www.fusfoundation.org/diseases-and-conditions/overview.
Accessed Feb. 2, 2017.
2. Focused Ultrasound Foundation. “Technology Overview.”
www.fusfoundation.org/the-technology/overview.
Accessed Feb. 2, 2017.
3. Focused Ultrasound Foundation. “Mechanisms of Action.”
www.fusfoundation.org/the-technology/mechanisms-of-action.
Accessed Feb. 2, 2017.
Radiation Oncology | PRODUCTS |
Tomotherapy Treatment Planning
RayStation 6, the latest release of RaySearch’s radiation therapy treatment
planning system, adds significant new functionality and a wide range of
general improvements. Major additions include forthcoming support for
Accuray TomoTherapy systems. The new release enables planning for both
conventional linacs (linear accelerators) and tomotherapy systems, giving
clinics one point of control for all treatment planning needs. All contouring
work can be done in one workspace. It is also possible to plan combined
treatments and accurately calculate combined dose. Clinical support for
tomotherapy systems is pending final validation and will be included in
a service pack to be released in the near future. Other highlights include:
Monte Carlo dose calculation for proton pencil-beam scanning (PBS); PBS
planning with block apertures; simultaneous co-optimization of multiple
beamsets; magnetic resonance (MR)-based planning, using MR-image as
planning image; and auto-recovery.
RaySearch | www.raysearchlabs.com
Online Educational
Resource for Healthcare
Professionals
Helical Tomotherapy Support
Mobius Medical Systems’ DoseLab, the complete TG-142 solution, fully supports
American Association of Physicists in Medicine (AAPM) TG-148: QA for Helical
TomoTherapy. DoseLab provides comprehensive support for all tests outlined in
TG-148, including: Y-jaw divergence/beam centering, Y-jaw/gantry rotation plane
alignment, treatment field centering, MLC alignment, gantry angle consistency, couch
speed uniformity, couch translation/gantry rotation, interrupted treatment, laser
localization and cheese phantom image quality. Trend analysis of TG-148 results can
be performed in DoseLab’s web-based database viewer alongside all daily, monthly
and annual quality assurance (QA) results for linear accelerators.
Varian Medical Systems launched a website for
the exchange of clinical information, scientific
research and expert opinion around the
management of cancers and other conditions,
with an emphasis on applications utilizing
radiotherapy. The site offers video- and audiotaped symposia that Varian has supported or
sponsored in the recent past, including a recent
self-assessment continuing medical education
(SA-CME) accredited webinar, and a selection of
bibliographies organized by disease site. In the
future the site will house additional resources
including webinars with educational credits,
information about sponsored/translational
research and clinical trials, case studies and
FAQs for the medical professional.
Varian Medical Systems |
www.medicalaơairs.varian.com
Mobius Medical Systems | www.mobiusmed.com
MR-guided Focused Ultrasound
Insightec Ltd’s Exablate Prostate system received CE
mark for treating locally confined prostate cancer
with MR-guided focused ultrasound (MRgFUS).
One in six men will be diagnosed with prostate
cancer during their lifetime. Many patients are
diagnosed with locally confined disease with
low or intermediate risk for progression. In these
cases, patients may choose active surveillance or
an intervention. Currently available treatments
including prostatectomy, which surgically removes
the entire prostate, and radiation therapy, targeting
the full prostate, demonstrate good cancer control,
however there is high risk of impotency and
incontinence. The Exablate Prostate system is based
on Insightec’s proprietary MRgFUS. It uses focused ultrasound waves to precisely target and ablate (destroy) the targeted tissue in the prostate, while minimizing
damage to adjacent structures. The treatment is done under magnetic resonance imaging (MRI) guidance for high resolution visualization of the patient’s anatomy as
well as real-time temperature monitoring. The treatment does not require incisions and is performed in a single session, allowing patients to quickly return to normal
activity. The Exablate Prostate system features an endorectal probe integrated into a treatment bed which is compatible with GE 1.5 and 3T MRI. Ultrasound energy is
delivered by a high-frequency, 1,000-element phased array transducer which delivers focal therapy under MRI guidance and real-time thermal feedback. This enables
the physician to control and personalize the therapy.
Insightec Ltd | www.insightec.com.
Imaging Technology News | itnonline.com | March 2017
21
INFORMATION TECHNOLOGY
Technology Report
RSNA Technology
Report 2016:
In an itnTV video, Contributing Editor Greg Freiherr
describes enterprise imaging advances shown at
RSNA 2016.
By Jeff Zagoudis
I
n the days before picture archiving and communication systems (PACS),
collaboration between various hospital departments was extremely
difficult, as clinicians could only consult with each other in person. Today,
enterprise imaging allows providers to interact from wherever they are
with all of the relevant clinical data stored in one place.
ITN Contributing Editor Greg Freiherr spoke with
numerous enterprise imaging vendors at the 2016
Radiological Society of North America (RSNA) annual
meeting for a feature video, available on itnTV, to find
out how they are working together with clinicians to
enable this enhanced level of care.
Combining Technology and
Clinical Experience
The goal of enterprise imaging is to ensure all
members of the patient management team have the
information necessary to make the best decisions
about patient care. While technology is an important
part of any enterprise imaging (EI) strategy, the tools
are only helpful if they are wielded with the proper
clinical experience.
With Conserus Imaging Fellow, its newest EI
offering at RSNA 2016, McKesson looks to assist
radiologists with both aspects of their enterprise
imaging strategy. “You need to work with each
institution to understand how are they going to
differentiate on value-based medicine. What is
important to them?” said Scott Galbari, McKesson
vice president of marketing and portfolio, in the
itnTV video.
22
March 2017 | itnonline.com | Imaging Technology News
Conserus Imaging Fellow collects all relevant
patient data — including surgical history,
medications, lab results and admission/discharge
notes — and consolidates it into one easy-tonavigate interface. According to Galbari, the goal is to
find “the needle in the haystack” — the information
that is most important for the radiologist to make a
decision about that patient and that particular clinical
disease state.
The system offers full electronic health record
(EHR) integration; a vendor neutral design and
flexible configuration options allow it to be used
in any hospital setting. “They don’t have to search
for it, they don’t have to make phone calls to other
departments. It’s all right there,” Galbari told Freiherr.
24/7 EHR Integration
The electronic health record provides another
common area for all departments to contribute their
expertise to patient care by creating a patient-centric
view of the information. And with radiology no
longer the sole executor of medical imaging, the EHR
acts as an archive of its own for all image types.
Sectra believes that clinicians should have access
to these repositories anywhere at any time of day or
night in order to be the most efficient.
“With all our customers growing
and the consolidation
in the market, having
IT systems available
24/7, 365 days a year
is of key importance,” said
Mats Bjornemo, VP of product management for
Sectra. “It’s both for driving efficiency — because
if it’s not available, all the other tools you have
won’t make a difference — and also for patient
safety.” The company prides itself on maintaining
high uptime percentages, showing 99-100 percent
uptime at five large hospitals in five different
countries over a three-year period.
Ultimately, Sectra believes that its PACS can
be used to bring together a care team that
has previously been fragmented into separate
technological silos. “By helping each other out and by
divvying up the work across the entire health system,
Enterprise
Imaging
Sectra believes that its
PACS can be used to bring
together a care team
that has previously been
fragmented into separate
technological silos.
Pecaitis told Freiherr that organizations often
purchase new technologies, such as vendor neutral
archives (VNA) as short-term solutions. “We look
at it more as a medical library, and those images
are an organizational asset, part of an enterprise
imaging platform and strategy,” Pecaitis said. With its
Enterprise Imaging Platform, Agfa can help mitigate
information gaps for clinicians and develop a crossenterprise workflow. Customers can opt for a bestof-breed approach or utilize the company’s platform
approach to enterprise imaging.
Streamlining Workflow
rather than siloing it like before, you actually
get more precise diagnosis,” Anders
Osterholm, Sectra VP of sales
operations, told Freiherr in
the video.
Bridging the
Information Gaps
As the U.S. healthcare system shifts focus to patientcentered, value-based care, hospitals have had to get
creative to maintain quality care while lowering costs to
enhance patient satisfaction — a key metric under the
Affordable Care Act and other reform efforts. Imaging
can have an impact on all three areas, something
radiologists must be aware of. “Radiologists really need
to look holistically at the patient and the quality of care
for that patient, and not just be so focused on driving
transactional reading and revenue volume,” said Frank
Pecaitis, senior VP of sales for Agfa Healthcare, in the
itnTV video.
One of the biggest challenges of coordinating care
across multiple departments is that each department
often has its own unique workflow, so finding
information can be difficult for people outside their
own group. An enterprise imaging system can help
solve this problem by offering one unified workflow
that all -ologies can follow.
“When you talk about enterprise imaging, it’s no
longer radiology looking out, but rather, coming
from a CIO perspective, how is this helping me?
How is this integrated into my ecosystem?”
Cristine Kao, global marketing and growth
operations director for Carestream, told Freiherr
in the itnTV video.
Carestream has made this principle the bedrock
of all of its enterprise imaging/viewing technologies,
powered by what it calls the Unified Core. The zerofootprint technology aims to consolidate all clinical
content to a single point of access, supporting four
workflow pillars:
• Acquisition — Images can be acquired
anywhere with any device, including at the point of
care with mobile devices.
• Management — The Unified Core allows care
team members to access relevant information at
the point of care or anywhere else via zero-footprint
worklists.
• Archiving — The system creates an enterprise
repository for all clinical images, whether from
radiology or visible light photos at the point of care.
• Viewing — Zero-footprint technology also
allows both providers and patients to quickly and
easily access medical records. In addition to medical
image viewing, however, solutions like Carestream’s
Clinical Collaboration Platform allow clinicians and
administrators to take a wider view of performance
analytics to ensure they are delivering the highest
quality of care. This includes looking at performance
from both an operational (e.g., report turnaround
times) and a clinical perspective (e.g., ensuring data is
gathered and reported accurately).
Adaptive Intelligence in Enterprise Imaging
Artificial intelligence, also known as deep
learning and machine learning, was one of
the hottest topics at RSNA 2016, with multiple
vendors showing off applications in radiology
and enterprise imaging. Philips Healthcare has
incorporated the technology into its IntelliSpace
PACS via a new feature it calls Illumeo. Ilumeo
employs adaptive intelligence similar to a map
application on a smartphone: If the user searches
for a restaurant in the map app, the algorithm will
Imaging Technology News | itnonline.com | March 2017
23
INFORMATION TECHNOLOGY
Technology Report
Conserus Imaging Fellow from McKesson collects all relevant patient data — including surgical history, medications, lab results and admission/discharge notes — and consolidates it into one easy-to-navigate interface.
drop a locating pin on the map, and then provide
information on the hours and menu in anticipation of
what the customer needs. Illumeo behaves similarly,
isolating the clinical focus of an image and providing
any relevant information the radiologist will need to
interpret the image.
“Rather than just opening a study, scrolling
through and having to figure out what the
radiologist was referring to in the report, we can
actually guide them to the right locations and show
them what is relevant,” said Eran Rubens, chief
technology officer, enterprise imaging,
Philips Healthcare IT in the itnTV video.
Lifecycle Management
Philips also introduced the Universal Data Manager
for its IntelliSpace PACS that allows differing
lifecycle management rules for different types of
images (e.g., ordered vs. non-ordered) as they are
archived. This can be extremely helpful in a modern
environment where newly integrated hospital
systems often bring with them different, complex
infrastructures and rules for image storage. For
example, a hand X-ray may be archived for a year
while a pediatric image might have to be held for
decades. The Universal Data Manager sits on top of
all existing infrastructures to create its own rulesets.
Efficient Data Exchange
As previously discussed, any enterprise imaging
system must fit into the workflows of the various
departments it serves to best facilitate efficient
data exchange. At RSNA 2016, Mach7 Technologies
showcased its best-of-breed hybrid approach that
combines platform and VNA approaches.
“What is different is how we’ve simplified it,
how we’ve made the data workflow behind the
scenes much easier to implement and much
24
March 2017 | itnonline.com | Imaging Technology News
easier to execute on those standards, and therefore
consumable by IT teams and PACS administrators,”
said Eric Rice, Mach7 chief technology officer. Recent
updates have been driven by considerations like
what steps does a wound care physician have to take
to associate a picture or video captured at the point
of care with an encounter or a patient in the EHR. The
goal is to improve workflow so clinicians can access
all of the relevant data needed for treatment.
“As much as we are a VNA company, we’re
the viewer’s capabilities, enabling it to perform
both image-enabled EHR functionality and a fully
diagnostic workflow — a rarity, according to Lexmark
Chief Technology Officer Claudio Gatti, who told
Freiherr that most zero-footprint solutions are only
capable of basic viewing functionality.
“We started with radiology, and we can now
essentially perform all the functions of a traditional
PACS in a zero-footprint manner. Then as a strategy
we started specializing in other specialties,” Gatti said
in the itnTV video.
This year, according to Gatti, NilRead’s
capabilities expanded to include digital pathology
and light-based specialties. The digital pathology
functionality has been cleared for use in Europe,
and the company hopes to have U.S. clearance
within the next 12 months.
For light-based imaging, such as surgery
and gastroenterology, Lexmark added video
functionality, and clinicians can even select
smaller portions of a larger video to be archived
into the EHR.
“The goal of enterprise imaging is to ensure all
members of the patient management team have
all of the information necessary to make the best
decisions about patient care.”
a medical imaging company that delivers a
complete solution across workflow to better
exchange, manage and share medical imaging
data,” Rice told Freiherr.
Expanding the Enterprise Reach
Among EI vendors at RSNA 2016, Lexmark is one
of the newest, having entered the market less than
three years ago via acquisition of VNA companies and
others focused on the capture and sharing of photos
and videos. Most recently, Lexmark purchased
Claron Technology, adding the NilRead viewer to its
product portfolio. Since then, Lexmark has expanded
If there was a common theme among
enterprise imaging vendors at RSNA 2016, it was
that medical practices must break out of their
individual silos to form truly collaborative patient
management teams. Enterprise imaging has the
potential to break these patterns, change the
decision-making environment and may even
change the way decisions are made. itn
Editor’s note: Watch the video “Technology
Report: Enterprise Imaging 2016” for additional
information at http://bit.ly/214upMZ.
Information Technology | PRODUCTS |
Medical Imaging Monitor
LG Electronics USA Business Solutions is introducing clinical and surgical monitors, marking
its entry into the growing global medical imaging devices market. The LG 8 MP Clinical
Review Monitor is a 27-inch IPS monitor driving 3,840 x 2,160 pixels, specifically designed
to increase hospital staff efficiency by enabling streamlined workflows and multitasking. In
addition to enhanced brightness levels, this monitor provides healthcare professionals with
wide viewing angles, minimal color shift and accurate images. The monitor is Digital Imaging
and Communications in Medicine (DICOM)-compliant, which means that grayscale tones are
corrected to maintain image accuracy. Finely calibrated to ensure consistency across multiple
devices, the monitor is equipped with backlight stabilization technology to guarantee stable
luminance levels. Dynamic Sync Mode reduces input lag, while Flicker Safe and Reader Mode
settings help reduce eye strain experienced by doctors and nurses working long shifts.
LG Electronics | www.lg.com/us
Medical Image Sharing
NexGenic LLC, the developer of the image sharing solution
ImageInbox, announced that its latest release includes cloudbased features for clinical specialists and hospital customers to
provide comprehensive image tele-consultation services, which
can be rapidly integrated into existing clinical operations and
workflows. The latest version also includes options for cloud
image viewing and supports EEG and non-DICOM image formats.
Developed for more than a decade in support of millions of
diagnostic image transfers, ImageInbox provides a turnkey
image capture and utilization platform for individual physicians,
healthcare organizations, clinical trial sponsors and patients that
need to send essential images securely at a moment’s notice.
NexGenic | www.nexgenic.com
4-D Advanced Vis MRI Software
Arterys received 510(k) clearance from the FDA for its Arterys Software in November, paving
the way for use in clinical settings for the quantification of cardiac flow. This includes 4-D
Flow and 2-D Phase Contrast workflows, and cardiac function measurements. Arterys plans
on launching the product in the United States through a partnership with GE Healthcare’s
ViosWorks product. Powered by the Arterys software, ViosWorks will be the first clinically
available cardiovascular solution that delivers cloud-based, real-time processing of images
with resolutions previously unattainable, according to the company.
Arterys | www.arterys.com
Expanded Clinical Guidelines
National Decision Support Company (NDSC) recently announced expanded CareSelect
solutions that cover a wide variety of care settings and healthcare services including the
ABIM Foundation’s Choosing Wisely Campaign. NDSC’s CareSelect helps to accurately
render clinical guidelines for electronic medical record (EMR) delivery, leveraging existing
clinical documentation and creating a seamless user experience within the EMR workflow.
The expanded solution now includes clinical and business logic covering medication, lab
and blood management, as well as a complete set of advisories based on the Choosing
Wisely Campaign. The CareSelect platform exchanges data with the EMR in real time
to perform clinical calculations
against evidence-based guidelines
and pathways. This enables the
caregiver to choose alternate
tests or clinical pathways based
on the guideline. This advanced
functionality can be coupled with
the CareSelect benchmarking and
reporting tools to ensure success.
Enterprise Viewing Platform
Calgary Scientific Inc. announced version 6.0 of its
enterprise image-viewing platform, ResolutionMD.
The platform continues to expand interoperability
capability across the healthcare enterprise,
offering institutions a better way to connect
clinicians and patients to each other and their data.
ResolutionMD provides a scalable pathway and
seamless integration between picture archiving
and communication systems (PACS), vendor neutral
archives (VNAs), cloud archives, electronic medical
records (EMRs), patient portals and hospitaldeveloped apps. The new version includes multimonitor support, expanded DICOM modalities in
departments outside radiology, extended image
sharing with third-party providers, FHIR data
integration, expanded HTML5 capabilities and
mobile measurements. Scalability improvements
include both virtualized and physical server
deployments with CPU or GPU options.
Calgary ScientiƤc | www.calgaryscientiƤc.com
National Decision Support Company
www.nationaldecisionsupport.com
Imaging Technology News | itnonline.com | March 2017
25
BUSINESS
Patient-centered Care
Prioritizing
Patient
Satisfaction
As the healthcare system begins placing greater emphasis on
value, providers should make patient satisfaction a high priority
throughout the whole patient experience
By Jeff Zagoudis
W
hile patient welfare has always been the guiding principle of the
healthcare system, patient satisfaction has only become a priority
recently. Reform efforts of the last several years have focused on fixing
aspects of the system that have been headaches for patients — namely
high costs and care process inefficiencies. As the healthcare system
continues to change, the importance of patient satisfaction will continue being a guiding
metric for progress — a reality that could have a major impact on healthcare providers.
Those at the leading edge of change have stressed
the importance of practicing patient-centered care.
What this means and how it is done are driving
discussions, including during the 2016 annual
meeting of the Radiological Society of North America
(RSNA) last November in Chicago. Several presenters
there addressed why patient satisfaction is important,
how the system is changing to accommodate it and
what it means for the future of radiology.
Why Patient Satisfaction is Important
At first thought, one might believe patient
satisfaction and patient welfare are interchangeable
concepts, as improved health is the primary reason
patients seek out medical care. The reality, however, is
that patient health is just one part of a larger picture.
Practicing patient-centered care and prioritizing
patient satisfaction requires providers to look beyond
health outcomes and other clinical benchmarks to
the overall patient experience.
“Imagine you don’t know anything about
healthcare; how would you want to interact with the
26
March 2017 | itnonline.com | Imaging Technology News
healthcare system? Would you want to be 50th in a
queue at the on-call center to schedule a radiology
test?” said Ella Kazerooni, M.D., professor of radiology,
associate chair for clinical affairs and director of
cardiothoracic radiology, University of Michigan
Health System, to an audience of healthcare
professionals at RSNA 2016.
This traditional radiology experience (dubbed
“Radiology 1.0” by Kazerooni), from scheduling
an exam all the way through to results
communication and billing, has placed little
emphasis on patient involvement, with patients
being shepherded from one place to the next with
little to no explanation. This has slowly given way
to what Kazerooni calls “Radiology 2.0,” where
more patients are coming into the radiology
department via referrals from other physicians.
Patient portals emerged in this era, allowing
online scheduling of appointments, and viewing
of imaging and lab results.
Through both phases of the radiology experience
there have been various metrics to measure
performance and guide improvement efforts.
Kazerooni pointed out, however, that the majority of
these metrics have focused on clinical quality.
“We’ve always thought quality was a CT with the
lowest radiation exposure for the question being
asked, or the fastest report turnaround time and
access to a test this afternoon,” she said. “But in the
value world, you see that quality as perceived by the
patient includes a lot of the patient experience. This
disconnect is very real.”
Financial Incentives for Quality
Bridging this divide has been one of the driving
forces in the transformation of the healthcare
industry the last several years from a volume-based
culture to a value-based one. Perhaps the most
significant legislation in this arena has been the
Medicare Access and CHIP Reauthorization Act of
2015 (MACRA), which will provide financial incentive
for hospitals and healthcare providers to practice
quality and value in medicine.
Under the guidelines of MACRA, the Centers for
Medicare and Medicaid Services (CMS) announced in
2016 it would be creating a Quality Payment Program
to develop new incentives to focus on quality
care and patient satisfaction. One of the primary
mechanisms of the program will be the Merit-Based
Incentive Payment System (MIPS), which will provide
financial incentives for Medicare physicians based on
four performance categories: Quality, Advancing Care
Information, Clinical Practice Improvement Activities
and Cost. There will be an option for physicians
to include patient experience data in their annual
reporting for additional incentive pay. While MIPS
reimbursements are not scheduled to begin until
2019, performance evaluation under the new criteria
does begin this year.
Kazerooni emphasized that it is important to
collect data — be it through surveys, patient
satisfaction scores or other metrics — throughout the
process. Then, as changes are implemented, the same
metrics should be used to remeasure the effects of
the changes.
Remembering the difference between
professionally centered metrics and patientcentered metrics is key. For example, a provider may
believe that if a patient needs multiple tests, it would
be best to schedule them all in one day so the patient
does not have to come back multiple times. This type
of schedule can be exhausting for patients, though,
and they may actually prefer to come back and do
one test at a time.
Reaching Radiology 3.0
Five Keys to Quality Improvement Success
With MACRA, MIPS and other changes yet unknown
in the future, radiology is poised to enter yet another
phase, which Kazerooni calls Radiology 3.0. This
next evolution will center on the healthcare “team,”
on which patients will play an integral role. “People
demand a lot and radiology costs a lot, so we need to
reassociate with our patient base,” she said.
To establish a philosophy of patient- and familycentered care, Kazerooni told the audience there are
four core concepts that must be practiced:
While the idea of a quality improvement project
as described may be exciting, it is important for
the project team and its leaders to come in with
a solid plan, said David B. Larson, M.D., MBA,
associate professor of radiology and associate chair
of performance improvement, Department of
Radiology, at Stanford University School of Medicine.
“If you’ve made no preparations and you just start
into it, you’re probably going to fail,” Larson told his
RSNA audience, “and that’s OK. You can learn from
that failure and move on.”
To minimize the chances of failure, however, Larson
noted that every successful quality improvement (QI)
project considers five factors:
•
•
•
•
Respect and dignity;
Information sharing;
Participation; and
Collaboration.
Most importantly, these tenets must be integrated
throughout all parts of the patient experience. For
example, if a department wants to optimize its CT
operations, the project team should start by speaking
to the patient check-in desk and ask questions
about those procedures — i.e., are the exam request
processes easy to access, understand and navigate?
Do the people working the call center have good
customer service skills?
1. Leadership: In order for change to fully set in,
the team must understand the leadership hierarchy
of their organization to know who is best suited to
help facilitate the change(s). The leader’s role is not to
solve the problem, Larson stressed, but rather enable
their team to solve the problem.
2. Method: Knowing how the team is going to
approach the project is critical to ensure everyone
is on the same page. While those with a healthcare/
science background may be more familiar with
the scientific method (centered on answering a
question), Larson said QI projects are more suited
to an engineering-design approach (centered on
solving a problem). “You should be developing
solutions to a problem and refining them as you go,”
he told the audience.
3. Resources: The project team must have a strong
knowledge of all of the resources at their disposal
before they begin, or they will be unable to overcome
obstacles along the way. Larson gave the example
of calling a team meeting, but attendance is sparse
because people are unable to break away from
their other work. “Ask leadership up front, ‘What
resources are we going to have available to us?’
and ‘If we need more personnel/equipment/other
resources along the way, are you willing to make
that commitment?’ ” he said.
4. Culture: Every organization has its own unique
culture — the way people interact, what informal
procedures are in place and who talks to whom.
“You have to ask yourself: Who will be impacted by
the change and is everyone who will be impacted
included in the process?” Larson said.
5. Execution: Ultimately, the project team must
have the ability, desire and perseverance to execute
the improvement plan. The key, according to Larson,
is choosing the projects and project roles wisely.
The Future of Quality in Radiology
As healthcare reform continues forward in the
future, providers must ask themselves, “How can
we think more like patients, what information will
they want to know, and what measures can we
use?” said James Duncan, M.D, Ph.D., professor
of radiology in the Division of Interventional
Radiology at Washington University School of
Medicine in St. Louis. Duncan wrapped up the
RSNA session by considering these questions and
offering two predictions:
1. Patients will want “more” and “better” from
all aspects of healthcare. Maintaining patient
satisfaction, in Duncan’s mind, will require more
predictable processes and outcomes throughout the
healthcare system — as well as more transparency
on pricing and expertise. The ultimate goal, he said,
should be better integration across the system and
care better tailored to individual patient needs.
2. Providers will be working with more data. In
order to provide the level of care patients will expect,
Duncan warned providers will need to rely on
traditional sources — speaking with and observing
patients — as well as newer ones like patient
monitors and patient-entered data. “Other industries
have figured out how to get around it and maybe
we should too,” Duncan said of allowing patients to
contribute their own information.
The ultimate goal will be to use all of this data and
information to reduce uncertainty in the process of
patient care. Duncan said patients are more aware of
how much data is collected but that they are often
frustrated with how it does not seem to be used.
By prioritizing patient satisfaction throughout their
entire experience, providers can begin to build the
relationships that will be key to successful outcomes
moving forward. itn
Imaging Technology News | itnonline.com | March 2017
27
Passion can’t be trademarked.
GE Mammography is driven by a singular passion: perfecting 3D Mammography. So while some
may be focused on trademarking 3D Mammography, we’ve been busy perfecting it. The result: our
technology provides images of outstanding detail and superior diagnostic accuracy, which helps
clinicians provide exceptional care and puts patients’ minds at ease. And it does it all with the same
low dose as a 2D exam, the lowest patient dose of all FDA approved DBT systems.1
gehealthcare.com/mammography
1. GE screening protocol consists of 3D CC/MLO + V-Preview CC/MLO, V-Preview is the 2D synthesized image generated by GE Seno Iris mammography software from GE DBT images. FDA PMA P130020/S001
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P130020S001, Data on file.
Average glandular dose in digital mammography and digital breast tomosynthesis: comparison of phantom and patient data. Bouwman, R. W. and al., et. 2015, Physics in Medicine & Biology, pp. 7893-7907.
COMPARISON CHART
BREAST TOMOSYNTHESIS
Finding Value
in Digital Breast Tomosynthesis
By Melinda Taschetta-Millane
N
ew research presented by Stephen
40-49 shows improved outcomes in recall rates
Rose, M.D., chief medical officer of
and cancer detection rates; that DBT addresses a
Solis Mammography and president
primary concern regarding screening women in
of Rose Imaging Physicians Group,
their 40s by reducing recall rates; and adding DBT
Houston, at the 2016 Radiological
to mammography takes about the same amount of
Society of North America (RSNA) annual meeting
time as digital mammography, and captures around
found recall rates, cancer detection and invasive
60 pictures (radiologists can now see cancers as early
cancer detection for women under age 50 were
as Stage 0 with tomo).
significantly improved with the addition of digital
“Our study is confirming the benefits of
breast tomosynthesis (DBT) to mammography.1
tomosynthesis. For a disease with no known form
However in January 2016, the U.S. Preventive
of prevention, early detection is key and the earliest
Services Task Force (USPSTF) sparked controversy
detection is with tomosynthesis, especially in women
when it changed its recommendations, advising
under 50 years old with dense beast tissue,” said Rose
women to start their mammograms at age 50. This
in a statement released by RSNA.
reversed the previous standard set by the American
The Players
Cancer Society (ACS) in October 2015 in its “Breast
Today there are four tomosynthesis systems on the
Cancer Screening for Women at Average Risk:
market. Hologic’s Selenia Dimensions mammography
2015 Guideline Update” that advised women to be
system offers earlier detection of breast cancers,
screened by age 45 and then every two years after
clearer lesion images and reduction in the number of
age 55.2 It also seemed to ignore the fact that the
men and women who were key in making these
unnecessary biopsies, minimizing patient anxiety and
policy changes were not peer-reviewed radiologists,
unnecessary costs.
used 2-D mammography research and did not
GE’s SenoClaire 3-D breast tomosynthesis offers
consider the benefits of DBT. They also did not
clarity at a low dose using a short X-ray sweep around
take into account that according to the American
the compressed breast with only nine exposures.
Cancer Society’s Breast Cancer Facts & Figures
SenoClaire is an add-on feature to existing Senographe
Report,3 in 2015, 20 percent of women diagnosed
Essential and Senographe Care platforms.
with invasive breast cancer were under the age
Siemens Mammomat Inspiration Prime with
of 50 when diagnosed. In addition, women under
Tomosynthesis Option is a breast tomosynthesis
the age of 50 tend to be more likely to have dense
add-on for its Mammomat Inspiration digital
breast tissue, which increases the potential for a
mammography platform. The premise of the
false negative result.
technology is that it shoots multiple images and
DBT is defined as multiple low-dose full-field
creates a 3-D dataset that produces multiple slices,
projection images of the breast obtained from
between 40-140, at 2 mm each, that can be rolled
different angles that form an arc. The images are
through and looked at in different sections.
then used to reconstruct a 3-D image of the breast,
New to the market is Fujifilm Medical Systems
resulting in a clearer view without the distraction of
U.S.A. Inc.’s DBT software upgrade for its Aspire
overlapping tissue.
Cristalle digital mammography
For the study, Rose and Solis
system, which recently received
Mammography collected data
premarket approval (PMA)
from Jan. 1-Dec. 31, 2015, from
from the U.S. Food and Drug
Fujifilm Medical Systems
a network of community-based
Administration (FDA). The optional
www.fujifilmusa.com
screening centers of women 40-49
DBT upgrade is now available in
to investigate if the addition of DBT
the United States. According to
GE Healthcare
to mammography could improve
Fujifilm, radiologists using the
www.gehealthcare.com
screening performance outcomes
Aspire Cristalle full field digital
for women under the age of 50.
mammography (FFDM) system
Hologic
As reported at RSNA 2016, the
with DBT will realize enhanced
www.hologic.com
effects of adding DBT in women
clinical efficiency compared to
under 50 were decreased recall
using FFDM alone. This includes
Siemens Healthcare
rates by 6 percent; increased cancer
superior diagnostic accuracy and
www.usa.siemens.com/healthcare
detection rates by 67 percent;
lower recall rates for non-cancer
and increased positive predictive
cases. Known as Amulet Innovality
Scranton Gillette Communications
values for recall by 56 percent.
outside of the United States, the
obtained the product specifications from
Other conclusions from the study
optional DBT upgrade has been
the manufacturers.
noted that the addition of DBT
widely available in Europe, Asia
to mammography in women
and Latin America since May 2013.
Participants
The Aspire Cristalle FFDM system with DBT combines
Fujifilm’s hexagonal close pattern (HCP) detector
design, advanced image processing and image
acquisition workflow to optimize patient dose while
maximizing image quality.
Looming on the horizon is the Planmed Clarity
3-D DBT system, which is FDA-pending and has
received the CE mark and is currently available for
sale in the European Union and other countries
where the CE mark applies. Planmed’s new method
is said to significantly improve image accuracy and
allows even the smallest details to be captured with
great precision.
Coverage Issues
A recent report from market intelligence firm
Infiniti Research discussed the growth of DBT in
the United States, highlighting the benefits and
acknowledging the barriers to continued adoption.
The report states that despite all of the benefits of
this technology, many have been unable to take
advantage of them. In the United States, numerous
health insurance companies will not cover
procedures that use this new technology, despite
its effectiveness. While Medicare and Medicaid do
cover it, private insurers do not, forcing patients to
settle for a 2-D mammogram even when it is not the
best option.
Some states are fighting this, however.
According to Infiniti Research, Connecticut has
brought in a new law this year that requires insurers
to cover 3-D mammograms if the patient asks
for them. “While the state’s Insurance Department
argues that this will be very costly to implement,
supporters of the law disagree. Although the initial
cost of acquiring new equipment will be high, the
accuracy of these tests will eliminate the need for
many 2-D tests. The costs should also fall as the
equipment and tests become more prevalent,”
according to the report. itn
References:
1. Rose, S. “Tomosynthesis Impact on Screening Patients 40 to 49.”
Radiological Society of North America 2016 Scientific Assembly
and Annual Meeting, Nov. 27 - Dec. 2, 2016, Chicago IL. archive.rsna.
org/2016/16015111.html Accessed Feb. 7, 2016
2. Kevin C. Oeffinger; Elizabeth T. H. Fontham,; Ruth Etzioni; et al. JAMA.
2015;314(15):1599-1614. doi:10.1001/jama.2015.1278
3. American Cancer Society. Breast Cancer Facts & Figures 2015-2016.
Atlanta: American Cancer Society, Inc. 2015.
Comparison chart compiled by
Imaging Technology News
Scranton Gillette Communications assumes
no responsibility or liability for any errors or
omissions in this chart.
Imaging Technology News | itnonline.com | March 2017
29
COMPARISON CHART
Breast Tomosynthesis Systems
Company Name
Fujifilm Medical Systems U.S.A., Inc.
Product name
Aspire Cristalle
FDA cleared, year
Aspire Cristalle 2014, with Tomo 2017
FDA indication of equivalent/superior
to FFDM
N/S
CE mark, year
N/S
What differentiates your product
from competitors
GE Healthcare
Senographe Essential with SenoClaire
Hologic
Siemens Healthineers
Senographe Pristina
Selenia Dimensions (Avia 3000/6000/9000) and Genius 3D
Mammography exams
Mammomat Inspiration Prime with Tomosynthesis Option
2014
December 2016
FDA PMA for tomosynthesis February 2011
Tomo: 2015, tomo only: 2016
Superior diagnostic accuracy at the same dose as 2-D FFDM
Tomosynthesis approval PMA pending at FDA
Superior to FFDM
Superior to FFDM
2013
2016
2008
2006
Innovative hexagonal close pattern (HCP) detector yields more
efficient capture vs. conventional square pixels, resulting in lower
patient dose; iAEC intelligent auto recognition of differentiating
tissues, muscle & implants for optimal exposure conditions
GE Digital Breast Tomosynthesis delivers superior diagnostic
accuracy at the same dose as 2-D FFDM, the lowest patient
dose of all FDA approved DBT systems; ASIR DBT, a calcification
artifact correction iterative reconstruction algorithm that delivers
off-plane images much improved in terms of both in-plan and
out-of-plane artifacts; provides improved scatter rejection, with
equal or improved image quality, especially for thicker breasts
GE Healthcare set out to reshape the mammography experience
focused on comfort for patients: improving the overall exam
experience with an inviting appearance and unique features such
as the rounded detector edges and slim profile to allow for a
more comfortable breast examination and may help reduce compression anxiety; confidence for technologists: a fully integrated
digital platform and thoughtful ergonomic design featuring tube
head park position to improve patient positioning; clarity for
radiologists: building upon our continued development in image
quality focused on detector design, tube and filter combinations
and a universal grid
Selenia Dimensions system’s Genius 3D Mammography exam
offers the following advantages over 2-D mammography: an
increase in invasive breast cancer detection; a reduction in false
positive recalls, minimizing patient anxiety and unnecessary
costs; proven superior clinical performance to 2-D mammography, providing exceptionally sharp images, seamless transition
between imaging modes, sophisticated user tools that simplify
operation, advanced clinical applications, tomosynthesis-guided
biopsy and ergonomic design for patient comfort and ease of
operation
Prime technology using software to replace the antiscatter grid
saves up to 30% dose without compromise in image quality;
wide angle (50°) for tomosynthesis for superior depth resolution,
decreased noise and separation of overlying tissue compared to
narrower angle breast tomosynthesis images
Number of WW installs
N/A
N/S
N/S
Approximately 4,000 breast tomosynthesis systems
>3,500
Scan time, 60 mm breast
4 sec
N/S
N/S
3.7 seconds (using C-View software)
N/S
Tomo dose for ACR phantom
1.2 mGy
N/S
N/S
1.45 mGy
N/S
Combo (Tomo + 2-D) dose for ACR
phantom
1.3 mGy
N/S
N/S
1.45 mGy (using C-View software)
N/S
Upgrade from FFDM (hardware/software required)
Aspire Cristalle software only, Aspire HD or HD+ full system
replacement
Hardware and software required to upgrade to 3-D
N/S
S/w upgrade
SW upgrade
Tomo require add-on unit or built in
Built in (software upgrade only)
N/S
N/S
Built in
Built in
Reconstruction time for 60 mm breast
N/S
N/S
N/S
<5 seconds
N/S
Tomo-guided breast biopsy available
Not yet avail in U.S. (in use outside of U.S.)
N/S
N/S
Yes
Yes
Size of tomo screening paddles
18 x 24 and 24 x 30
N/S
N/S
Various paddles available; no limit; 18 x 24 cm, 24 x 30 cm, small
breast paddle, etc.
24 x 30 cm, 30 x 36 cm
Tomo with needle localization
paddles supported
No
N/S
N/S
Yes
Yes
Combo mode imaging supported
Yes
N/S
N/S
Yes
Yes, with or without Prime Technology
Compression time for combo study,
60 mm breast
4 sec
N/S
N/S
~10 sec. (from initial compression to end of X-ray exposure)
27 sec
PACS requirements
BTO
N/S
N/S
DICOM objects: MG, DBT, SC, GSPS; DICOM functions: Q/R, DICOM
store, DICOM send, DICOM, store commit
DICOM objects: MG, CT, BTO
Generator type
High frequency
High frequency single-phase power supply
High frequency single-phase power supply
High frequency
High frequency
kV range
22 - 49 in 1 kV increments
22 to 49 kV
22 to 49 kV
20 - 49 kV
23-35 kV
mAs Range
2 - 600
4 to 500 mAs (depending on track, filter and kV)
4 to 600 mAs (depending on track, filter and kV)
3 - 150 mAs
2 to 630 mAs
mA range
20 - 200
Molybdenum target: 100 mA from 25 to 30kV on large focal spot,
40 mA from 25 to 30 kV on small focal spot; Rhodium target: 62
mA from 25 to 30 kV on large focal spot, 35 mA from 25 to 30 kV
on small focal spot
Molybdenum target: 100 mA from 25 to 30kV on large focal spot,
40 mA from 25 to 30 kV on small focal spot; Rhodium target: 62
mA from 25 to 30 kV on large focal spot, 35 mA from 25 to 30 kV
on small focal spot
10- 200 mA
N/S
AEC detector
Automatic, semi-automatic, manual
Two exposure modes: automatic optimization of parameters
(AOP) and manual mode available
Two exposure modes: automatic optimization of parameters
(AOP) and manual mode available
Yes; both AutoAEC and manually select AEC regions
Inteligent AEC algirithim analyses each breast indivdally for
thickness and breast composition to optimise exposure
Parameters controlled
Fully automatic: sets kV, mAs, target/filter, grid, AEC, dose level;
semi-automatic: sets mAs; manual: all selections manually input
i-AEC - used clinically - will perform a detailed analysis of the
pre-exposure image to determine the optimum exposure (kVp
and mAs) conditions for the view; ideal for implant cases
Track, filter, kVp, mAs, AOP or manual
Track, filter, kVp, mAs, AOP or manual
kVp, mAs, filter, AEC method, AEC location
Stand: patient name, breast thickness, force in N; AWS: kVp, mAs,
filter, AEC, Opdose,
Density reporting software (list if it is
optional or integrated and who is the
software vendor)
Integrated, Volpara
Optional; Volpara Density 3D - specifically designed and cleared
for 3-D/tomo mammography systems
N/S
Quantra breast density assessment software option from Hologic;
no other vendor software is validated for Hologic
Compatible with Volpara and iCad breast density software
vendors
What information is recorded
N/S
Breast density score compliant with BI-RADS fifth edition
N/S
Breast density score compliant with BI-RADS fifth edition; scores
for each breast, temporal information, various
Vendor dependent
What density parameters are used
and what is listed in the report
N/S
Breast density score compliant with BI-RADS fifth edition
N/S
Breast density score compliant with BI-RADS fifth edition
Vendor dependent
Dose software record dose
N/S
N/S
N/S
Advanced connectivity license
Vendor dependent
How is density information stored or
transferred
N/S
Structured report and secondary capture
N/S
Structured report and secondary capture
Stored with images and transfered - vendor dependent
Type (CCD, CsI, aSe)
aSe direct-conversion
Patented needle structure CsI scintillator, single piece
construction
Patented needle structure CsI scintillator, single piece
construction
aSe
aSe
Spatial resolution
50 x 50 μm pixel resolution
100 μm in both 2-D and tomo modes, no binning
100 μm no binning
70 μm; FFDM resolution: 70 μm; tomo resolution: 85 μm
85 μm in 2-D, 85 μm in tomo
Matrix, pixels
24 x 30 cm: 4,728 x 5,928 = 28,027,584 pixels
3,062 x 2,394 pixels; approx 14 MB per image
2,850 x 2,394 pixels; approx 13 MB per image
3,328 x 4,096
2,816 x 3,584
Standard size
24 x 30
Detector size 24 x 30.7 cm
Detector size 24 x 29 cm
3,328 x 4,096
2,816 x 3,584
High-resolution size
24 x 30
Detector size 24 x 30.7 cm
Detector size 24 x 29 cm
3,328 x 4,096
2,816 x 3,584
Imaging area: Standard size, cm
18 x 24, 24 x 30
Detector size 24 x 30.7 cm
Detector size 24 x 29 cm
24 x 29
24 x 30 cm
Imaging area: High-resolution
size, cm
24 x 30
Detector size 24 x 30.7 cm
Detector size 24 x 29 cm
24 x 29
24 x 30 cm
Additional features
Innovative hexagonal close pattern (HCP) pixel design engineered
to deliver higher acquisition efficiency for finer detail, higher
DQE, higher MTF and lower dose than conventional square
pixel arrays
Senographe Essential detector, 100 μm (no binning in tomo); DQE
average values: 69% at 0 lp/mm, 61% at 2 lp/mm (average data
for 2016 production detector)
DQE at IEC 62220-2-3 equivalent spectrum, at 75 μGy: 70%
(+/-3) at 0.5 lp/mm and 64% (+/-3) at 2 lp/mm
Supports dual energy imaging; selenium based direct capture
technology
Full detector readout, no pixel binning
Workstation
3 MP
Dual core Kontron workstation: 4 GB memory, 500 GB disk, 7,200
RPM; image storage 30,000/50,000 large/regular field of view
Quad core Intel i5 workstation
Yes
Yes
Monitor size, inches
21.3 in
2 types of display available: 1 MP LCD monitor; 48 cm (19 in.)
medical grade; 1,280 x 1,024 pixels (landscape); high luminance
- up to 300 Cd/m²; contrast ratio: 2000:1; viewing angle: 170
degrees; mounted on a rotating arm for easy in-room access; 3
MP monitor display; high performance color TFT 3MP monitor;
54 cm (21.2 in.); 2,048 x 1,536 pixels (landscape); brightness:
1,000 Cd/m²; contrast ratio: 1,400:1; viewing angle: 170 degrees;
mounted on a rotating arm for easy in-room access
2 types of display available: 1 MP LCD monitor; 48 cm (19”)
medical grade; 1,280 x 1,024 pixels (landscape); high luminance
- up to 300 Cd/m2; contrast ratio: 2000:1; viewing angle: 170
degrees; mounted on a rotating arm for in-room access – 3 MP
monitor display: high performance color IPS 3MP monitor; 54 cm
(21.2”); 2,048 x 1,536 pixels (landscape); brightness: 1,000 Cd/
m2; contrast ratio: 1,400:1; viewing angle: 170 degrees; mounted
on a rotating arm for in-room access
Imaging monitor: 21.3 (2 MP/3 MP); control monitor: 17 in.
1 MP or 3 MP, one or two montiors (optional)
Hard disk capacity
N/A
1 internal 500 GB, 7,200 RPM
1 internal 250 GB disk for the system, 1TB for image storage
1 TB (min.)
2 TB
Memory
N/A
4 GB
8 GB
8 GB RAM (min): Avia 3000; 16 GB RAM (min): 6,000/9,000
12 GB
Breast Density and Dose Reporting
Digital Detector
Acquisition Workstation
30
March 2017 | itnonline.com | Imaging Technology News
Comparison Chart Compiled by Imaging Technology News
Scranton Gillette Communications assumes no responsibility or liability for any errors or omissions in this chart.
Editor’s Note: Additional submitted information also appears on our website at www.ITNonline.com.
Company Name
Fujifilm Medical Systems U.S.A., Inc.
N/A = Not applicable N/S = Not specified
GE Healthcare
Hologic
Siemens Healthineers
Networking capabilities
N/A
2 Gigabit ethernet port; DVI display; DICOM 3.0 platform:
modality worklist user; storage provider; storage commitment
user; query/retrieve user; basic grayscale print user; verification
provider; DICOM-compliant CD-RW data interchange
4 Gigabit ethernet port; DVI display and port connector; DICOM
3.0 platform: modality worklist user; storage provider; storage
commitment user; query/retrieve user; basic grayscale print user;
verification provider; DICOM-compliant CD, DVD-R/-RW and USB
data interchange
Ethernet
Adjustable height
N/A
N/S
N/S
Available
Yes, 28.7-43.3 in
Multiple exposure control options
N/A
N/S
N/S
Yes
Yes, 3 different options
Gray levels
N/A
N/S
N/S
10 bit display
8,192 greyscales/ 13 bit
Additional features
N/S
Connectivity features: customizable Autopush to multiple DICOM
databases, autoprint, autodelete based on storage commitment,
modality perform procedure step user, connectivity to GE service
for remote diagnostic capability
N/S
Upgrade features available for enhanced ergonomics
syngo software, shared with all Siemens modalities and reading
solutions to reduce training requirements
Workstation
5 MP
SenoIris Diagnose
SenoIris Diagnose
SecurView DX
syngo.Breast Care
Monitor size, Inches
21.3 in
Dual 5MP 21.3” LCD display; single 12 MP 33.6” color LCD display;
19” TFT color monitor
Dual 5 MP 21.3” LCD display; single 12 MP 33.6” color LCD display;
19” TFT color monitor
Single 12 Megapixel 33.6 in. color LCD display with built-in
auto-calibration and 10 bit graphics card; high contrast dual 5
Megapixel 21.3 in. LCD display with built-in auto-calibration
and 10 bit graphics card; standard dual 5 Megapixel 21.3 in. LCD
display with 10 bit graphics card
Variable, dependent on customer requirements
Hard Disk Capacity
N/A
1 x 256 GB, 2 x 1 TB SSD (additional 1TB optional)
1 x 256 GB, 2 x 1 TB SSD (additional 1TB optional)
Minimum 3.5 TB, RAID 5, disk encryption
Variable, dependent on customer requirements
Memory
N/A
32 GB RAM
32 GB RAM
16 GB high speed RAM minimum
Variable, dependent on customer requirements
Networking Capabilities
N/A
10/100/1,000 base T ethernet
10/100/1,000 base T ethernet
10/100/1,000 base T ethernet
Variable, dependent on customer requirements
Archive/Storage
N/A
Enterprise archive
Enterprise archive
SecurXchange archive
Variable, dependent on customer requirements
Type
Eizo
Departmental PACS
Departmental PACS
Departmental PACS
Variable, dependent on customer requirements
Capacity
N/A
N/S
N/S
At least 3 TB
Variable, dependent on customer requirements
Gray Levels
N/A
N/S
N/S
N/S
N/S
Additional Features (space permitting)
N/S
Meets requirements of IHE radiology mammography imaging
integration profile-imaging display actor; capable of accepting
DICOM breast tomosynthesis objects
Meets requirements of IHE radiology mammography imaging
integration profile-imaging display actor; capable of accepting
DICOM breast tomosynthesis objects
Meets the requirements of IHE Radiology Mammography Image
Integration Profile- Image Display Actor; capable of accepting
DICOM BTO, CT, SCO
syngo software, shared with all Siemens modalities and reading
solutions to reduce training requirements
Anode Type
Rotating
Dual track anode: molybenum (Mo) enriched with vanadium
and rhodium (Rh)
Dual track anode: molybenum (Mo) enriched with vanadium
and rhodium (Rh)
Tungsten
Mo/W
Heat Capacity, HU
300,000
Anode heat storage capacity: 250 kJ (340 kHU)
Anode heat storage capacity: 250 kJ (340 kHU)
300,000 HU
2,430,000 HU (tube unit)
Heat Dissipation Rate, HU / Min.
60,000
N/S
500 W (40 kHU/min)
60 kHU/min
40.5
Target /Filter Combinations
w/Rh
N/S
Mo/Mo and Rh/Ag
Tungsten/aluminim
Mo/Mo, W /Ro, W/Mo
Focal Spot Size, mm
0.1 mm and 0.3 mm
0.1 and 0.3 IEC on each target
0.1 and 0.3 IEC on each target
0.3
0.15 / 0.3 mm
Collimation
Yes
Filters: molybenum 0.030 mm; rhodium 0.025 mm
Filters: molybenum 0.030 mm; silver 0.030 mm
N/S
Automatic collimation to compression paddle
18 x 24 cm
Yes
Yes
Yes
Yes
Yes
24 x 30 cm
Yes
Yes
Yes
Yes
Yes
Movement locks
Electromagnetic
Gantry locked when compression force applied
Gantry locked when compression force applied
Electro-magnetic brakes
Electromechanically
Assembly movement
N/S
N/S
N/S
N/S
N/S
Rotation
-190 to +190
+ 185 to - 165 degrees
+ 180 to - 180 degrees
+180 degress to -140 degrees (total rotation)
+ 180 to - 180 degrees
Vertical, cm (inches)
69-150 (27.2-59.1)
Floor to image receptor distance: from 65 to 150 cm
Floor to image receptor distance: from 65 to 150 cm
70 - 141 cm (28.3- 55 in.)
69 (27.2 in.) to 150 cm (59.1 in.) (object table)
SID, cm
65
66
66
70
65 (25.6 in.)
Scale Guide
N for force and mm for thickness
Yes
N/S
Yes, lb or N
N/S
Handswitch
Yes (customer option)
Dual foot-pedals for column height and compression adjustments
Dual foot-pedals for column height and compression adjustments
No
Yes
540 with W/Rh tube using 50 micron filter
N/S
N/S
1,232 mR/sec @ 28 kVp (0.7 mm Al filter)
N/S
L x W, cm (inches)
108 x 60.4 (42.5 x 24)
Choice between two radiation shields: integrated to the control
console (height: 1,900 or 2,200 mm); standalone
N/S
84 W x 138 L cm
86 x 195 cm (33.9 in.) x (76.8 in.)
Thickness
0.5 mm Pb equivalent; designed to meet the relevant requirements of 21 CFR 1020 and IEC 60601-2-45:2001
N/S
N/S
12 mm leaded acrylic, 0.5 mm Pb/ 35 kV per IEC 60601-2-45
0.5 mm lead equivalent
Compression system
Auto and manual compression
Motorized/manual
Motorized/manual
N/S
Opcomp, intelligent compression
Force, Newtons
0-200
Motorized up to 20 daN; manual up to 30 daN
Motorized up to 20 daN; manual up to 27 daN
Manual: max 300 N; pre-compression force: 67 to 134 N; full
range compression force: 89 to 178 N
30-200 N
Grid Ratio
6:1 41 lines/cm
2D ratio 5:1 frequency 36l/cm - 3D grid for DBT acquisition
Grid ratio: 11:1
N/A for tomo
5:1, 31 lines /cm
Bucky
N/A
24 x 31 cm
N/S
N/A for tomo
Reciprocating
Magnification device
1.8x
1.5 and 1.8 (2-D)
1.5 and 1.8 (2-D)
N/A for tomo
Optional
Stereotactic device
Optional
Yes (2D)
N/S
Affirm
Optional
Film ID system
N/A
Digital detector, no film
Digital detector, no film
None
No
Label printer
N/A
N/S
N/S
None
No
Power requirements
N/A
Input frequency: 50Hz/60Hz; input voltage: single phase
200/208/220/240 V~, APC smart UPS 750 VA
Input frequency: 50 Hz/60 Hz; input voltage: single-phase 200240 V~; EATON UPS 5P650 650 VA
Gantry: 2080/208/220230/240 VAC; AWS:
100/120/200/208/220/230/240 VAC
208 V, 230 V, 240 V, 277 V, ± 10%
H x W x D, cm (inches)
N/A
Gantry: 1,930 x 700 x 1,270 mm; acquisition station: 1,560 x 708
x 395 mm; generator 1,330 x 640 x 436 mm
Gantry: 2,020 x 720 x 1,312 mm; acquisition station: 1,885 x
775 x 368 mm
Gantry: 66 W (26 in.) x 223 H (87.8 in.) x 138 D cm (54.25 in.);
AWS: 135.6 W (53.4 in.) x 204 H (80.3 in.) x 122 D cm (48.4 in.)
235 (92.5) x 65 (25.6) x 117.5 (46.3)
Weight, kg (lb)
N/A
Acquisition station: 217 kg; gantry: 420 kg; generator: 160kg
Gantry: 394 kg; control station without monitors: 198 kg
Gantry: 400 kg (882 lbs); AWS: 209 kg (460 lbs)
350 kg (770 Ibs)
Optional accessories
N/A
Options: 24 x 31 cm ergonomic paddle that conforms to the
breast, 19 x 23 cm ergonomic sliding paddle that conforms to
the breast, 1.5 and 1.8 magnification stands with dedicated
paddles (19 x 23 cm, round spot, square spot), square spot sliding
compression paddle, round spot sliding compression paddle,
2-D localizer with standard and round spot biopsy paddles, X-ray
remote control hand switch, hydraulic exam chair, bar code
reader, X-ray protective shield, mobile mounting kit, stereotaxy
add-on (2-D), senoIris Review station providing technologist easy
access to prior images and reports in the exam room
Additional 24 x 29 cm paddle; additional 19 x 23 cm sliding
paddle; 24 x 29 cm flexible compression paddle; 19 x 23 cm
flexible and sliding compression paddle; 10 x 23 sliding implant/
small breast compression paddle; square spot sliding compression paddle; round spot sliding paddle; 2-D localization 19 x 23
Swiss cheese sliding compression paddle; 2-D localization 19 x 23
sliding standard compression paddle; 2-D crosshair device; X-ray
protective shield; bar code reader
Optional accessories for gantry include but are not limited to
biopsy add-on (Affirm), paddles, mag stand, tomo face shield
Moodlight, mag table, biopsy unit, Prime technology
Warranty
1 year
1 year system warranty
1 year system warranty
12 months
1 year standard
Ethernet, DICOM and IHE compliance
Review Workstation
X-Ray Tube
Positioning Assembly
Radiation Output
mR / Sec. @ 28 kVp
Radiation Shield
Imaging Technology News | itnonline.com | March 2017
31
WOMEN’S HEALTH | PRODUCTS |
Breast Tomo Monitor
Eizo Inc.’s RadiForce GX550 is a 21.3-inch, 5 megapixel
monitor for viewing detailed digital breast tomosynthesis
and mammography images. It is the successor model to the
RadiForce GX540 and features superior imaging capability
and ease-of-use. The RadiForce GX550 features Eizo’s
Sharpness Recovery technology, with which the decrease
in sharpness (MTF) is restored. This allows healthcare
professionals to display an image safely on the monitor that
is true to the original source data, even at high brightness
levels. The monitor’s new design features thinner, black front
bezels, making it easier to focus on images in dark reading
rooms, while the original white stripe design around the sides
of the monitor presents a fresh, clean aesthetic to promote
a comfortable, user-friendly environment. For keeping the
workspace efficient, the monitor’s width, height and depth
were reduced by 21 mm, 36 mm and 45.5 mm respectively – a
28 percent difference compared to its predecessor. The width
of the side bezels was reduced by approximately half to 13.5
mm – the thinnest in the industry for 5 megapixel monitors,
according to Eizo. This allows users to comfortably view two
monitors side by side to compare images. The company
has received U.S. Food and Drug Administration (FDA)
510(k) clearance for digital breast tomosynthesis and digital
mammography for the RadiForce GX550.
Breast Imaging Workstation
Three Palm Software released verson 1.8.2 of its breast imaging workstation,
WorkstationOne. It is a total integration of imaging and informatics for breast
imaging, which provides native functionality to generate diagnostics reports
and patient letters. This mechanism is integrated into the reading workflow, so
that reporting information is captured as the case is read, and is transparently
used to populate customizable templates. The reports are saved in a variety
of formats, including DICOM standard mechanisms that can be archived to
any picture archiving and communication system (PACS) and accompany
the studies for reference in future years. Generated DICOM formats include
secondary capture, encapsulated PDF and structured reports. The 1.8.2
release of WorkstationOne builds on its existing comprehensive support
for mammography, which includes seamless integration of tomosynthesis
and breast projection images from any vendor into the workflow; display
of mammography computer-aided detection (CAD) reports (including 3-D
tomosynthesis CAD reports with enhanced workflow); and simultaneous
display of related modalities and reports. WorkstationOne was also shown
in a number of partner booths at RSNA, including PACS and full-field digital
mammography (FFDM) vendors, as well as the major vendors of highresolution mammography monitors.
Eizo | www.eizo.com
Three Palm Software | www.threepalmsoft.com
Integrated
force sensors
LED pressure
indicators
X-ray transparent
foil
Compression
Paddle (small)
Sensitive Sigma Paddle controller
Personalized Compression
Sigmascreening’s Sensitive Sigma Paddle enables personalized compression
for better quality mammograms without unnecessary discomfort for patients.
The patented Sensitive Sigma Paddle has multiple sensors that measure each
breast to optimize compression for each breast. Based on breast size and tissue
stiffness, the device calculates the pressure to achieve an optimal compression
of 75 mmHg and allows for a highly reproducible procedure. Investigational in
the United States, the device is CE-marked and is actively being used at breast
screening centers and hospitals in England, Germany, Sweden, The Netherlands,
Belgium and Switzerland since receiving CE-mark last year.
Sigmascreening | www.sigmascreening.com
32
March 2017 | itnonline.com | Imaging Technology News
TMIST Tomosynthesis Trial
Researchers from The Ottawa Hospital Breast Health Centre
and the Ottawa Integrative Cancer Centre (OICC) have
opened the Ottawa site of the Lead-In to the Tomosynthesis
Mammographic Imaging Screening Trial (TMIST). The Breast
Health Centre is one of three clinical trial sites to launch the
Lead-In in Canada. It is expected that shortly this trial will be
integrated into a larger U.S./Canada TMIST, managed by the
ECOG-ACRIN Cooperative Clinical Trials Group. TMIST is the first
large randomized, multi-centre study to assess whether a novel
3-D digital tomosynthesis technology combined with 2-D
digital mammography may be more effective at reducing the
incidence of advanced breast cancers than conventional 2-D
mammography alone. Previous smaller studies suggest that
this new kind of mammography can increase breast cancer
detection and reduce the rate of false positives and recalls for
women who do not have cancer. If successful, implementation
of this technology would provide greater assurance of an
effective test, reduce patient stress and anxiety, and ultimately
reduce costs to the healthcare system. The current Lead-In
study aims to enroll 6,300 women in Canada, including 2,000
from Ottawa. Women attending mammographic screening at
the Breast Health Centre may be approached to participate.
Canadian Cancer Trials | www.canadiancancertrials.ca
Breast Screening Software
VolparaEnterprise 2.0 software helps breast imaging providers deliver high-quality, personalized breast screening. It delivers key performance indicators (KPIs)
for hundreds of performance and quality metrics, including positioning, compression and equipment utilization. The Microsoft Azure–based solution provides
continuous quality assurance and performance monitoring through dynamic, interactive dashboards. Updated with every mammography or tomosynthesis exam, the
VolparaEnterprise ConstantQuality metrics may help facilities comply with the U.S. Food and Drug Administration’s (FDA’s) new EQUIP inspection program. Designed to
support large or small enterprises, VolparaEnterprise software enables breast imaging providers to provide objective evidence to demonstrate compliance and quality
of care. Users can perform rapid quality control checks to optimize the productivity and efficiency of imaging resources, to help reduce costs through the reduction of
retakes, and to increase staff effectiveness.
Volpara | www.volparasolutions.com
Breast Density
Category Assessment
Software
The FDA has granted 510(k)
clearance to Statlife’s
DenSeeMammo, a software
solution for breast density category
assessment. DenSeeMammo
provides a standardized and
automatic breast density evaluation
that mimics radiologists’ visual
assessment according to the
BI-RADS 5th Edition guidelines. The
images from the mammography
equipment are compared to
a database of images that
were previously quoted by a
consensus of Mammography
Quality Standards Act (MQSA)
radiologists specialized in breast
imaging. The DenSeeMammo
software can be combined with
Statlife’s MammoRisk software for
breast cancer risk assessment; it
provides a breast density category
assessment, a risk evaluation, and a
patient report with a personalized
screening program. DenSeeMammo
is a software application intended
for use with digital mammography
systems. DenSeeMammo estimates
BI-RADS breast density value by
analyzing digitally processed
2-D mammograms using a fully
automated comparison procedure.
It provides a BI-RADS breast
density 5th Edition category to aid
radiologists in the assessment of
breast density. DenSeeMammo is
compatible with images obtained
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33
the last read
Greg Freiherr
Beware the Invisible Gorilla
A
slam against radiology is probably the last thing anybody would expect
to see in fallout coming from the new U.S. president. And so far there has
been nothing. In literally thousands of Trump tweets over the last several
years, radiology has not been mentioned once. And that is exactly why
radiology needs to be on the lookout. Big time!
It’s not what the tweets say but the effect they have —
how Trump tweets distract and how they might provide
cover for the gorilla that could be coming for radiology.
To see this, we first must consider the phenomenon of
“Trump tweeting.” In early December, the President-elect took
aim at Boeing for “out of control costs” on a new Air Force One
— “more than $4 billion. Cancel order!” he tweeted.
Never mind that the Air Force, according to Reuters,
had previously said it planned to spend $1.65 billion for
two of the jets. Never mind that the initial contract of
$25.8 million had been awarded to reduce risk and lower
the cost of the program, according to the Pentagon’s
daily digest of arms deals.
A big company with lots of military contracts, booming
sales of commercial planes and a soaring stock price,
Boeing was an irresistible target for the soon to be
Commander in Chief. And world media from CNBC to the
BBC, The Guardian to WirtschaftsWoche quickly scrambled
to report the “news.”
The tweetfest continued after Mr. Trump moved into
the White House. And it wasn’t all about Boeing. In the
three weeks since inaugural day (Jan. 20 to Feb. 10), more
than 130 Presidential tweets were sent, according to a
search on Trump Twitter Archive. Those tweets gripped
the nation’s attention, appearing daily on websites and
in newspapers, nightly on network news, distracting the
public from the substance of what was going on.
To understand the significance of this for radiology, we
must consider the phenomenon of the “invisible gorilla.”
But first we must look at the economic barrage that
radiology has struggled against in recent years.
Hard Times
More than a decade ago, as editor of the newsletter
DI SCAN, I suggested in a series of commentaries that
radiology launch a public awareness campaign. Radiology,
I warned, was not properly appreciated by the public. And,
because radiologists
are “doctors’ docs,” it has
no grassroots support
among patients,
making it an easy
target for politicians
wanting to “do something” about spiraling
healthcare costs.
From 2006 to 2013,
the Centers for Medicare and Medicaid
(CMS) repeatedly cut
radiology payments.
The bundling of
reimbursement codes
for computed tomography (CT) of the
abdomen and pelvis
led to a
34
March 2017 | itnonline.com | Imaging Technology News
29 percent drop in payments in 2011, according to a study
by Thomas Jefferson University researchers. In 2012 and
2013, the volume of CT procedures dropped 5.5 percent
annually, according to the IMV Medical Information
Division.
In 2013 the Protecting Access to Medicare Act of 2014
(PAMA) directed CMS to develop an appropriate use
criteria (AUC) program for advanced diagnostic imaging
services, singling out magnetic resonance (MR), CT and
molecular imaging. It is no coincidence that the highest
profile modalities — the ones with the costliest machines
and the highest charges — continue to be lightning rods
for politicians. And that brings us to the gorilla and the
presidential tweets that could make it invisible.
Cognitive psychologists call this phenomenon of invisibility
“inattentional blindness.” (It is also known as perceptual
blindness and change blindness.) It happens when
observers see only what they are looking for, even when
other options are right in front of them.
This phenomenon was most famously demonstrated in
a study that asked volunteers to count the times players
passed a basketball. Absorbed in the counting, the volunteers
did not notice a person in a gorilla suit walking right through
the players.
Enter the Gorilla
Radiologists are not immune. In a study at Brigham and
Women’s Hospital in Boston, 24 radiologists were asked to
detect lung nodules. “A gorilla, 48 times the size of the average nodule, was inserted in the last case ... 83 percent of the
radiologists did not see the gorilla,” the researchers wrote, even
though the majority, as revealed by eye tracking, looked
directly at it.
Will radiology fail to see the approaching gorilla of
reimbursement cuts, if and when it comes again? There are
plenty of reasons to be alert.
In his bid for the Presidency, Mr. Trump attacked
ObamaCare relentlessly as Republicans voted repeatedly
— and unsuccessfully — to repeal it. Both had cited this
program as the cause of rising insurance premiums. Hoping
to leverage the seismic shift in Washington that occurred
last November, Mr. Trump and Congressional Republicans
are trying to come up with a “replace/repair” plan for
ObamaCare.
Assuming they succeed in the ouster of ObamaCare, if
insurance premiums (or healthcare costs) rise, Congressional Republicans and Mr. Trump will want a scapegoat,
something the President can tweet about with impunity.
What branch of medicine will it likely be? (Hint: Which lacks
grassroots support? Which depends on costly machines and
high charges?)
Maybe it isn’t a bad idea for radiology to keep an eye out
for gorillas.
Greg Freiherr has reported on developments in radiology since
1983. He runs the consulting service, The Freiherr Group. Read
more of his views on his blog at www.itnonline.com.
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