FDA Clears iPhone, iPad Radiology App

15 Healthy Mobile Apps

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.