First FDA-approved medical device accessory cleared for Apple Watch

Above Apple Heart Study app

Available for iPhone and Apple Watch users in the US the Apple Heart Study app represents part of a "first-of-its-kind" research project that seeks to establish the potential use of wearables such as Apple Watch in detecting atrial fibrillation (AFib) - a condition associated with an increased risk of strokes and heart failure.

This is the first ResearchKit study in which Apple itself has served as the sponsor, and signals that the company is becoming more and more hands-on with its health efforts.

While the optical heart rate sensor found in the Apple Watch's main body can help detect some heart problems, EKM tests require more in-depth data to discover any underlying heart problems. It costs $200 and is on sale from Amazon and AliveCor's site, and you don't need a recommendation for a doctor to use it - it's meant for consumers, and anyone who might want to keep a closer watch on their heart or those concerned with heart issues like sinus heart rhythms or atrial fibrillation.

AFib is considered one of the leading causes of stroke, with 2.7 million Americans living with the arrhythmia, according to the American Heart Association. Many people don't experience symptoms, so AFib often goes undiagnosed.


Now AliveCor, a private medical health company headquartered in Mountain View, California, is releasing a new Apple Watch band that has a built-in EKG sensor. Working alongside the medical community, not only can we inform people of certain health conditions, we also hope to advance discoveries in heart science.

Apple is partnering with Stanford Medicine to perform the research.

If the app detects an irregular heart rhythm, the user receives an alert on their iPhone and Apple Watch, a free consultation with a study doctor, and an electrocardiogram patch for further monitoring.

Lloyd Minor, Dean of Stanford University School of Medicine stated that "Through the Apple Heart Study, Stanford Medicine faculty will explore how technology like Apple Watch's heart rate sensor can help usher in a new era of proactive health care central to our Precision Health approach". KardiaBand works with both Apple Watch sizes - 42mm and 38 mm - for $199. In our initial studies Apple Watch has been effective at surfacing irregular rhythms.

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