Well how about that - software developers are making it easy on me to write this series with yet another 510(k) clearance announced this week. The latest in cleared mobile health devices? The AliveCor mobile heart monitor.

This fantastic device attaches to an iPhone 4 or 4S and, in conjunction with the App, can run an EKG by placing the electrodes on the patient's fingers or chest. The new and novel aspect to it is its transfer of the signals to AliveCor's cloud server for easy viewing or sharing with medical personnel. Not only is it an EKG, but it seconds as a home monitoring device which, hopefully, could improve the survival rates for cardiac events.

Those developments are wonderful, but I see another aspect to this and other recently-announced 510(k) clearances:

Bulldozer used for wetland restoration by U.S. Fish and Wildlife Service

That's right - bulldozers. These software developers, the brave and potentially crazy, are taking the bold approach of being some of the first mobile medical device 510(k)s funneling through the FDA for clearance. It is a benefit to them as they can begin marketing their product, but it also clears the way for the next wave of developers. As the 510(k) paradigm is based on predicates, these initial clearances build the foundation for new products. The initial submissions become the template for subsequent devices.

So, for all the huffery-and-puffery surrounding the FDA's focus on mHealth, the industry should thank the first submissions for defining the regulatory path to success.


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