FDA Clears First Diagnostic Radiology Mobile App

It was a long regulatory road for the software developers, but the FDA this week finally cleared the first mobile app for diagnostic radiology.

The app, developed by Cleveland-based MIM Software Inc., received 510(k) clearance, becoming the first approved for viewing images and making medical diagnoses based on CT, MRI, and nuclear medical technology, according to the FDA.

“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,” William Maisel, MD, MPH, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health, said in a statement.

Images are compressed for secure network transfer and sent to the appropriate wireless device using the Mobile MIM software. A clinician can then measure the distance on the image and image intensity values and display measurement lines, annotations, and regions of interest, the FDA said.

“The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model,” the FDA said in a statement. “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.”

This week’s approval capped a journey that started in 2008, when Mobile MIM was featured as the first medical app in the Apple AppStore. It was later pulled from the store amid regulatory concerns. The company then submitted two 501(k) applications - the second of which languished with the FDA for 221 days - and both were rejected for insufficient data.

Mark Cain, MIM Software’s CTO, said it felt like the second application “got lost in a hole,” with no questions or follow-up from the FDA. Finally, the FDA’s tone and interest seemed to change, Cain said. Officials recommended the developers apply for another 501(k), which would include more study and data.

Cain called the latest attempt “remarkable,” adding the company experienced the FDA’s transparency and improved communication first hand. “They understand [mobile technology] is where it’s going, and they have the people there who are obviously keenly interested in these matters,” Cain said.

The approval seems to signals a shift at the FDA to a greater focus on mobile health applications.
“I think the veil is being lifted on the FDA’s approach to mobile devices and mobile applications and mobile health in general,” Cain said. “It’s exciting to see this is finally happening.”