FDA Approves EKG Reader for Apple Watch

The US Food and Drug Administration (FDA) has approved AliveCor’s KardiaBand, the first medical-grade accessory for Apple Watch to quickly detect normal sinus heart rhythms and atrial fibrillation.

The first FDA-cleared medical device accessory for Apple Watch can record an EKG in 30 seconds with a touch of its integrated metallic sensor. The strap communicates with the company’s app detecting abnormal heart rhythm and atrial fibrillation. It also has the ability to detect issues like palpitations, shortness of breath and irregular heart rate which could increase the risk of stroke.

“This is a paradigm shift for cardiac care as well as an important advance in healthcare,” Ronald Karlsberg, MD, FACC, board certified cardiologist, clinical professor of medicine, Cedars Sinai Heart Institute, David Geffen School of Medicine, UCLA, said in a statement. “Today, EKGs are available only in offices and hospitals, using complex equipment, and usually only after a life-threatening event, for example a stroke.”

Rather than needing a smartphone to receive a reading, FDA-cleared EKG analysis algorithms can be continuously and discreetly done just by touching the band’s integrated sensor.

“With an EKG device on the wrist, AFib can be detected wherever the patient is, 24 hours a day,” Karlsberg added. “In randomized research trials, KardiaMobile, the first AliveCor EKG device, proved to be superior to routine care provided by physicians. Today, KardiaBand is a giant leap in personalized health care.”

The band, which requires a subscription to AliveCor’s Premium service includes SmartRhythm notifications; unlimited EKG recordings; automatic detection of atrial fibrillation or normal sinus rhythm; the unlimited ability to send EKG readings via email; unlimited cloud history and reporting of all EKGs taken; weight and medications tracking; and a mailed monthly paper report on readings taken each calendar month.

AliveCor has also introduced SmartRhythm, a new feature within the Kardia app that uses artificial intelligence with inputs from Apple Watch’s heart rate and activity sensors to continuously evaluate the correlation between heart activity and physical activity. When the feature detects an abnormal heart beat, the device notifies users to capture EKG data.

"The Apple Watch was the game changer but paired with KardiaBand it has the potential to be a lifesaver," Vic Gundotra, chief executive officer, AliveCor, told MD Magazine. "KardiaBand is the world’s first and only FDA-cleared medical device for the Apple Watch, which now enhances the Watch from a lifestyle product to a medical device."

A press release has been made available.

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