Mobile MIM was one of the very first medical applications to debut in Apple’s AppStore when it first launched in 2008, but the application also has the distinction of being the first medical application pulled from the store because of regulatory concerns. Today those concerns are over: The US Food and Drug Administration has officially granted the mobile radiology application a 510(k) clearance.
“The application is the first cleared by the FDA 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 FDA stated in a press release this morning. “It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.”
The app enables clinicians to measure distance, intensity values, display measurement lines, annotations and regions of interest. The images are securely transferred to the app from a hospital or physician’s office through a secure network transfer facilitated by MIM.
“The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model,” the FDA wrote in its press release. “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 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.”
Mobile MIM was one of the only iPhone apps demonstrated during Apple’s keynote presentation that launched the Apple AppStore back in the summer of 2008.
“Of course, we were thrilled,” MIM Software CTO Mark Cain told MobiHealthNews in an interview last year. “We were one of eleven developers that presented during the keynote. That week we won an Apple Design Award for Best iPhone Healthcare & Fitness Application.”
That August MIM submitted their 501(k) for Mobile MIM and after some discussions with the FDA decided they had to remove Mobile MIM from Apple’s AppStore: “Then, over the next few months, we discovered that our proposed device raised more questions than we had anticipated. In order to make their determination, the FDA wanted more information than we had provided,” Cain explained to MobiHealthNews last March. “The process stalled out as we reviewed what we would have to do next. This 510(k) was declared not substantially equivalent (NSE) because of insufficient data.”
In June 2009 MIM resubmitted a 510(k) with more data from trials. After 221 days the FDA again deemed the app NSE: The FDA’s official position was that “displaying medical images for diagnostic use on a mobile/portable device” is a new intended use without predicate, and as such is a class III (premarket approval) medical device, according to Cain.
Luckily for MIM, the FDA’s opinion on that matter must have changed in the intervening months because today Mobile MIM has a 510(k) clearance. MIM’s experience is one of the few public accounts of the nuances of FDA regulation of mobile health services. The clearance some two and a half years later of an app that originally launched with Apple’s AppStore is surely a milestone for mobile health.
The industry — and the FDA — have come a long way since 2008. Read the FDA’s full press release below:
FDA clears first diagnostic radiology application for mobile devices
Provides wireless access to medical images for iPhone, iPad users
A new mobile radiology application cleared today by the U.S. Food and Drug Administration will allow physicians to view medical images on the iPhone and iPad manufactured by Apple Inc.
The application is the first cleared by the FDA 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). It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.
“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,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health.
Radiology images taken in the hospital or physician’s office are compressed for secure network transfer then sent to the appropriate portable wireless device via software called Mobile MIM. Mobile MIM, manufactured by Cleveland-based MIM Software Inc., allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest.
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 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 can experience significant variations in luminance levels even between mobile devices of the same model. 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 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.