FDA clears ECG accessory for Apple Watch

AliveCor, developers of electrocardiogram (ECG) technology, have received clearance from the U.S. Food and Drug Administration (FDA) for the KardiaBand, an accessory that will allow Apple Watch users to view ECGs at any time.

"This is a paradigm shift for cardiac care as well as an important advance in healthcare," said Ronald P. Karlsberg, MD, professor of medicine at Cedars Sinai Heart Institute and the David Geffen School of Medicine UCLA. "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 ECG 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 healthcare."

The KardiaBand, the first FDA-cleared medical device accessory for the Apple Watch, is capable of recording an ECG in 30 seconds to identify normal sinus heart rhythms and atrial fibrillation (AFib). Additionally, the Kardia application includes an added feature called SmartRhythm that uses artificial intelligence to interpret inputs from the watch to evaluate the correlation between heart rate and activity. SmartRhythm also notifies users to capture an ECG when heart rate and activity are out of sync.

"KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health," said Vic Gundotra, CEO of AliveCor. "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."