First medical device accessory for Apple Watch cleared by FDA

November 30, 2017 // By Rich Pell
Mobile heart solution developer AliveCor (Mountain View, CA) has announced FDA clearance of its KardiaBand wearable electrocardiogram (EKG) monitor in the U.S., allowing Apple Watch users to capture their EKG anytime.

The KardiaBand enables users to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib) - the most common heart arrhythmia. It can record an EKG in 30 seconds with a touch of its integrated sensor, and the results are displayed on the face of Apple Watch using the company's Kardia app.

The company has also introduced a new feature within the Kardia app called SmartRhythm, which uses artificial intelligence along with inputs from the Apple Watch's heart rate and activity sensors to continuously evaluate the correlation between the user's heart activity and physical activity. If SmartRhythm detects that heart rate and activity are out of sync, the device notifies users to capture an EKG with KardiaBand or with its portable EKG reader counterpart, KardiaMobile.

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

Atrial fibrillation, which affects more than 30 million people worldwide, is the most common heart arrhythmia and a leading cause of stroke. One in four people over the age of 40 are at risk for developing it, and, says the company, millions of people around the world are unknowingly living with it.

"This is a paradigm shift for cardiac care as well as an important advance in healthcare," says Dr. Ronald P. Karlsberg, MD FACC, Board Certified Cardiologist and Clinical Professor of Medicine, Cedars Sinai Heart Institute and David Geffen School of Medicine UCLA. "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