Interview: The iPhone medical app denied 510(k)

By: Brian Dolan | Mar 15, 2010        

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MIM Mobile iPhone App“The iPhone has created a new direction for our company,” Mark Cain, CTO, MIMvista said in June 2008. “We have taken a complex desktop application removed it from the realm of black art and placed it in the hands of physicians and patients. And we have only just scratched the surface.”

Cain’s remarks were part of his presentation at Apple’s World Wide Developer Conference in June 2008 — the event at which Apple launched the AppStore. Cain’s app, Mobile MIM, was included among the very first applications in Apple’s AppStore. Shortly after becoming available for download from the AppStore, however, the app was removed from the store and has not yet returned. The reason? FDA regulation.

MobiHealthNews recently caught up with Cain, who detailed MIMvista’s experiences with the FDA over these past two years. Read on for more about MIMvista’s wireless health regulatory headache.

MobiHealthNews: Mobile MIM was one of the first medical iPhone apps, why did MIMvista decide to create it in the first place?

Cain: We’ve been writing medical imaging software since 2003, and we love technology. It wasn’t a surprise that the March 2008 release of the iPhone SDK fueled our natural curiosity. We had to find out if we could take our workstation software and replicate it on the iPhone.

Two of our lead engineers, Jerimy Brockway and Dave Watson, downloaded XCode, learned Objective C, and built a prototype, all on their off hours, and in only one week. It was remarkable. We saw the CT scan on the iPhone, scrolled through slices, and realized that everything had just changed.

MHN: What does the MIMvista app offer?

Cain: Mobile MIM displays full-resolution medical images, like CT, MR, or X-rays, with easy-to-use image controls such as window/level, zoom, and pan. Obviously, on a small screen, zoom and pan are essential features.

How did you come to be onstage at the WWDC in 2008?

While talking with Apple’s Science and Technology Marketing Group regarding our workstation medical software, we mentioned that we were seeing what we could accomplish with the iPhone SDK. They were very interested in this, and after we had the first functional version, we submitted it for the Apple Design Awards. In the month preceding the June 2008 WWDC, we were contacted and asked if we could present our application at the event. Of course, we were thrilled. 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.

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