How to Classify a Mobile Medical App and Submit It For FDA Approval or Clearance

Monday, November 3, 2014

Source: MDDI

iPhones are the new medical device. It’s true. Every time I login to medical device news organizations, mobile health is one of the dominating topics of interest. Just (literally) before I wrote this article, FDA approved a Dexcom device that uses a secure wireless connection to transmit the glucose levels of a person with diabetes to the smartphones of up to five designated recipients, or “followers.”

This blurring of social interaction with medical devices is a frontier that several companies are seeking to pioneer, and it has become clear that mobile medical applications are the next big thing in medtech. Even the company I cofounded, Remind Technologies, has a mobile app component. Thus, it comes as no surprise that several of Medgineering's newest clients are either companies seeking to add a mobile app to their portfolio or mobile medical app startups.

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