iPhone medical app denied 510(k)

This isn't directly relevant to digital pathology, but I thought it was interesting; the Healthcare IT Consultant Blog has posted an interview: iPhone medical app denied 510(k):

“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.

I found this interesting on several levels; first, the increasing relevance of smartphones (and tablets) for delivery of medical applications, second, the need for (and difficulty in obtaining) FDA regulatory approval for such applications, and third, the interplay between the platform provider (Apple) and the application vendor (MIMvista). 

We will continue to follow this with great interest :)

Comments

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