FDA Clears EKG-Capable Apple Watch Band

The device is the first FDA-approved wearable medical accessory.

Heart disease is the leading cause of death for both men and women in the United States, and for providers looking to diagnose heart disease, ordering an electrocardiogram, or EKG, is the first step to detecting any unusual heart activity.

But what if an EKG could travel with a patient everywhere they go, able to provide patients and doctors with the data they need to diagnose heart issues without lengthy tests? That's the aim of the KardiaBand, an EKG sensor that lives on an Apple Watch band, which offers anyone the chance to keep a closer eye on their heart health.

The band, developed and produced by California-based company AliveCor, was approved by the Federal Drug Administration on Nov. 30 and is the first wearable medical accessory to be approved by the agency. It takes heart readings at five-second intervals and uses machine learning and individual algorithms designed by the company to detect and alert users to issues such as atrial fibrillation or sinus heart rhythm.

"We live in a world where consumers want to know every minute what's going on [in their bodies] and for the first time they can have a medical, clinical-grade, FDA-cleared tool," AliveCor CEO Vic Gundotra told Business Insider.

The band comes with several software offerings that allow consumers to either track their own health or provide their doctors with readouts of their heart activity. As the first FDA-approved wearable medical device, it aims to put consumers back in the driver's seat when it comes to their own health.

"If you look at medical products, a defibrillator, the pacemaker that my father have, they don't show anything to the consumer. It's all hidden to the consumer," said Gundotra. "The DNA of AliveCor is very different."

Dec 04 2017