FDA Clears Smart Watch EKG Device

Apple Watch with Kardia Band and app (AliveCor Inc.)

30 November 2017. The Food and Drug Administration approved an electrocardiogram, or EKG device, designed to work with Apple smart watches, according to AliveCor, developer of the device. The company, based in Mountain View, California, says it’s the first medical device for smart watches approved by FDA for marketing in the U.S.

The EKG device, known as KardiaBand, is built into the Apple Watch wrist band and connects to the watch itself to measure heart rhythms and detect atrial fibrillation, or AFib. Atrial fibrillation is a common problem affecting some 33.5 million people worldwide in 2010, including at least 2.7 million people in the U.S., according to CDC. AFib is an irregular heartbeat that can lead to stroke or heart failure, where heart muscle contractions in the upper chambers beat irregularly instead of in a regular rhythm.  Those irregular rhythms can cause blood to pool and lead to blood clots, including clots that move to the brain and cause a stroke.

AliveCor says the KardiaBand can record an EKG in 30 seconds and display the results on the Apple Watch face. The watch band contains a sensor where the person places a thumb for 30 seconds to detect and transmit heart rhythms to an app on the watch. The app has an algorithm that evaluates recorded heart rhythms and reports either a normal or irregular heartbeat, or asks the session be repeated.

The KardiaBand now has a feature called SmartRhythm that uses artificial intelligence to assess heart rate and physical activity measured on the Apple Watch’s built-in sensors. If the data from those sensors are not in sync, the wearer is advised to take an EKG. The company says a version of SmartRhythm is also built into the smartphone version, called Kardia Mobile.

As reported by Science & Enterprise in August 2017, a clinical trial in the U.K. showed more participants using the Kardia Mobile device detected atrial fibrillation than in the comparison group receiving routine care. Among the Kardia users, 19 new AFib cases were found in the 12 month test period, compared to 5 cases in the comparison group. All new AFib cases were confirmed by cardiologists and began treatment with anticoagulants.

The KardiaBand costs $199.00 and requires an annual subscription to AliveCor’s cloud-based analysis, storage, and alert service for $99.00 per year. The service includes sending of EKG reports by e-mail and a monthly printed report of EKG readings.

“KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health,” says AliveCor CEO Vic Gundotra in a company statement. “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.”

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