AliveCor launches new app with FDA-cleared AFib algorithm

By Jonah Comstock
04:38 am

alivecor_new_featuresSmartphone-enabled heart monitor device maker AliveCor has launched a new app for patients, which is both timed with the new iOS 8 launch and incorporates the atrial fibrillation algorithm the company received FDA clearance for in August.

In addition to the AF algorithm, the new app allows patients to track medications and symptoms and has enhanced search features and graphic capabilities, according to AliveCor.

“With AliveCor’s new app my patients can forgo pulse monitoring and paper-based logging which is often unreliable and incomplete,” Dr. Jonathan Steinberg, director of the Arrhythmia Institute Valley Health System at the University of Rochester School of Medicine, said in a statement. “When working with patients with suspected or diagnosed heart conditions, the AliveECG app assists me in determining which medications, habits and activities are truly impacting their heart health. I now have a more complete view about what is happening between appointments and can even give immediate advice about what to do next during an AF episode.”

AliveCor’s heart monitor, which is available for both Apple and Android phones, has had FDA clearance since last year and has been in use by patients since March. But up until now, consumers using the device would simply send their ECG readings to a board-certified cardiologist or cardiac technician, who would turn a response around in 24 hours — or faster for an additional small fee.

With the algorithm, patients can take the ECG reading and immediately find out if they have atrial fibrillation. Then they can contact a board-certified cardiologist to confirm the result, and take the print out to their own physician. AliveCor CEO Euan Thomson said that the algorithm has a 100 percent sensitivity (it never returns a false negative) and a 97 percent specificity (it returns false positives about 3 percent of the time). For obvious reasons, the algorithm was designed to err on the side of false positives.

“Our pretty strong belief is that if people did this, if they got the app and used it regularly, especially in the at risk population of people over 40, that they will catch atrial fibrillation that was previously undiagnosed, using a mobile technology,” Thomson said. “It’s got great value to patients. From a conceptual standpoint or from a mobile health perspective, I think we’re really delivering on the promise of mobile health in a very meaningful way.”


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