The U.S. Food and Drug Administration (FDA) announced last week that it has
given 510(k) clearance to a new mobile radiology application developed by
Cleveland, Ohio-based MIM Software. The software, called Mobile MIM, allows
physicians to view medical images on Apple's iPhone and iPad mobile devices.
Announced last week, the move marks the first time that the FDA has given
clearance to a mobile health application that will help clinicians view
images and make medical diagnoses based on computed tomography (CT),
magnetic resonance imaging (MRI), and nuclear medicine technology, such as
positron emission tomography (PET).
The news is yet another indication that mobile devices, particularly the
iPad, are gaining significant traction among doctors and other clinical
employees who are using the product in various hospital settings, according
to Irene Berlinsky, IDC's senior research analyst covering multiplay
services.
"The iPad is generating lots of excitement as a physician tool. Anecdotal
reports already exist of use in operating rooms to view images of the
patient during surgery," Berlinsky said. "The iPad's potential also extends
well beyond the OR: its high-image resolution, color, small size, and
wireless connectivity hold the promise of letting doctors examine patient
data quickly and from anywhere. Mobile MIM appears to be the first FDA-
cleared application to fulfill this promise."
According to the FDA, the Mobile MIM software is used when hospitals and
physician offices take radiology images that are compressed for secure
network transfer and then sent to the appropriate portable wireless device
via the Mobile MIM application.
While the agency stressed that the ability to view these images on Apple's
mobile devices it is not intended to replace full workstations, William
Maisel, chief scientist and deputy director for science in the FDA's Center
for Devices and Radiological Health, said in a statement that the technology
enables physicians to be less dependent on workstations.
"This important mobile technology provides physicians with the ability to
immediately view images and make diagnoses without having to be back at the
workstation or wait for film," Maisel said.
Mobile MIM allows the physician to measure distance on the image; gauge
image intensity values; and display measurement lines, annotations, and
regions of interest, the FDA said.
In its evaluation, the FDA reviewed performance test results on various
portable devices. These tests measured luminance, image quality (resolution)
, and noise in accordance with international standards and guidelines.
The FDA also said it reviewed results from demonstration studies with
qualified radiologists under different lighting conditions. All participants
agreed that the device was sufficient for diagnostic image interpretation
under the recommended lighting conditions.
The display performance of mobile devices, even in the same model, can
experience significant variations in luminance levels. The Mobile MIM
application includes sufficient labeling and safety features to mitigate the
risk of poor image display due to improper screen luminance or lighting
conditions, the FDA explained.
The agency also said the device includes an interactive contrast test in
which a small part of the screen is a slightly different shade than the rest
of the screen. If the physician can identify and tap this portion of the
screen, then the lighting conditions are not interfering with the physician'
s ability to discern subtle differences in contrast. In addition, a safety
guide is included within the application.
