FDA clears AliveCor’s KardiaBand ECG for Apple Watch

AliveCor said today that the FDA approved its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation.

First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.

AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the correlation between heart activity and physical activity using data from heart rate and activity sensors in the watch. The app prompts users to capture an ECG reading when heart rate and activity are out of whack either with KardiaBand or AliveCor’s portable KardiaMobile device.

“KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health,” AliveCor CEO Vic Gundotra said in prepared remarks. “These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help manage afib, a leading cause of stroke, and other serious conditions.”

“This is a paradigm shift for cardiac care as well as an important advance in healthcare,” added Dr. Ronald Karlsberg of Cedars Sinai Heart Institute and UCLA’s School of Medicine UCLA in Los Angeles. “Today, [ECGs] are available only in offices and hospitals, using complex equipment, and usually only after a life threatening event, for example a stroke. With an EKG device on the wrist, afib can be detected wherever the patient is, 24 hours a day. In randomized research trials, KardiaMobile, the first AliveCor [ECG] device, proved to be superior to routine care provided by physicians. Today, KardiaBand is a giant leap in personalized health care.”

The KardiaBand accessory goes for $199 and requires an annual $99 subscription to AliveCor’s Premium service, the company said.

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