Search Team

Search by Last Name
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

Client Alerts

Fish's Keith Barritt quoted in BNA's Medical Devices Law & Industry Report

February 9, 2011

Client Alerts

Fish's Keith Barritt quoted in BNA's Medical Devices Law & Industry Report

February 9, 2011

Back to News Listing

FDA Clears First Diagnostic Radiology Software Application for Apple iPhone, iPad

Keith Barritt (DC) was quoted in BNA’s Medical Devices Law & Industry Report.

A new mobile radiology application cleared by the Food and Drug Administration Feb. 4 will allow physicians to view medical images on Apple devices such as an iPhone and iPad.

FDA said the application, Mobile MIM, is the first the agency has cleared for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET).

The application is not intended to replace full workstations and is approved for use only when there is no access to a workstation, FDA said. According to FDA, radiology images taken in the hospital or physician’s office are compressed for secure network transfer, then sent to the appropriate portable wireless device using the Mobile MIM software.

Keith Barritt, an attorney at Fish & Richardson in Washington, said that the product’s apparent clearance through the 510(k) process “would be a victory for the entire wireless medical device industry.”

Barritt said the MIM product “is apparently the same, or closely similar, medical software that was rejected by the FDA about one year ago due to lack of an appropriate predicate device.” Barritt noted that the reported indications for use of the newly cleared product are limiting, because FDA makes it clear the software is for use only when there is no access to a workstation, and that the software is not intended to replace full workstations.

“While clearly a big step for MIM Software and the industry in general, this limitation reflects the FDA’s cautious approach with the use of mobile health technology,” Barritt said.

 

Reproduced with permission from Medical Devices Law & Industry Report, 5 MELR 78 (Feb. 9, 2011). Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com/

To read the entire article, click here.

Stay current with Fish Sign up for our Newsletter