Apple Watch Gets FDA Clearance to Put EKG Sensor on People's Wrists

The watch is quickly becoming a medical data device.


The Apple Watch is on its way to becoming a full-fledged medical wearable.

AliveCor, the company that makes FDA-cleared personal electrocardiogram (EKG) technology, announced approval of its KardiaBand technology in the U.S., allowing Apple Watch users to capture and display their EKG within seconds via an integrated sensor.

KardiaBand will detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia, making it the first FDA-cleared medical device accessory for Apple Watch. KardiaBand can record an EKG in 30 seconds with just a touch of its integrated sensor. Results from the Kardia App are displayed on the face of Apple Watch.

AliveCor is adding a new feature to its Kardia app called SmartRhythm, which will use artificial intelligence to monitor and evaluate the watch wearer’s heart rate and activity.

“KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health,” Vic Gundotra, CEO of AliveCor, said in a statement. He went on to explain that these new capabilities will allow people at risk to easily and discreetly check their heart rhythms for abnormalness capturing data to help their doctors manage conditions like Atrial Fibrillation (AFib), a leading cause of stroke.

AFib is known as the most common heart arrhythmia and a leading cause of stroke that affects more than 30 million people worldwide.

“This is a paradigm shift for cardiac care as well as an important advance in healthcare,” said board certified cardiologist Dr. Ronald P. Karlsberg. “Today, EKGs 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 EKG device, proved to be superior to routine care provided by physicians. Today, KardiaBand is a giant leap in personalized health care.”

AliveCor is said to use advanced A.I., mobile, cloud and micro-electrode technology to help advance preventative heart care. And now with the help of Apple Watch, consumers will be able to take advantage of the technology without the use of complicated devices.

The KardiaBand is available now for $199 and requires a subscription to AliveCor’s Premium service for $99 a year, which includes features like SmartRhythm Apple Watch notifications, unlimited EKG recordings and cloud storage, among others.


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