With FDA approval of its new algorithm, AliveCor's smartphone ECG becomes a diagnostic tool. Will mHealth as a whole follow suit?
When MD+DI first reported on a successful study by AliveCor to examine the efficacy of its smartphone ECG to screen for atrial defibrillation (AF), a form of heart arrhymia, company CEO Euan Thomson said the company was also looking to develop medical-grade algorithms into the system to provide automated analysis. This month the company has announced a 510(k) FDA approval for the first algorithm of this type.
AliveCor also lets users consult with certified cardiologists.
This algorithm, which is aimed at detecting AF, will be integrated into the new version of the AliveECG app that will be available in early September. “Current users will only need to update their AliveECG App through the App store. New users will just need to download the app. No new hardware is required and the app is free,” Thomson says. The algorithm is capable of detecting symptoms of AF through AliveCor's ECG mobile heart monitor and alerting patients through AliveCor's analysis service. Users will also be able to confer with a U.S. board-certified cardiologist or their personal physician regarding the results. “We worked very closely with FDA to make sure that not only was the algorithm accurate enough, but that the appropriate controls were in place to ensure the intended users of the algorithm have the ability to get physician analysis of those ECGs as well,” Thomson says.
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