- AliveCor’s KardiaBand app for Apple Watch successfully detected atrial fibrillation in participants in a Cleveland Clinic study.
- The portable electrocardiogram technology, which received FDA clearance in November, accurately identified AF versus normal sinus rhythm with 93% sensitivity and 84% specificity. Sensitivity rose to 99% when physicians reviewed the app's recordings, according to results published online in the Journal of the American College of Cardiology.
- Additional research by Mayo Clinic showed the app can detect high potassium levels in the blood. The sensitivity for the condition, called hyperkalemia, ranged between 9% and 94%. Both studies were presented at the ACC’s 67th Annual Scientific Session in Orlando.
The findings could support a move to commercialize KardiaBand, whose use to date has been limited to research. Atrial fibrillation is a leading cause of stroke, and hyperkalemia is associated with congestive heart failure, chronic kidney disease and diabetes.
The ability to spot both conditions has wide implications for population health management and remote patient monitoring. Between 2.7 million and 6.1 million people in the U.S. suffer from AF, according to the Centers for Disease Control and Prevention. Hyperkalemia affects an estimated 3.7 million U.S. adults.
KardiaBand is the first medical device accessory for Apple Watch to have FDA’s nod. The app lets Apple Watch users capture a 30-second EKG to detect normal heart rhythms and atrial defibrillation. Last fall’s clearance was widely seen as a boost for use of Apple Watch as a medical device, and the new trial results appear to support such a move.
The results come as Apple is adding more health features to Apple Watch and considering more medical uses. The Apple Watch Series 3, OS4, released in September, includes an enhanced heart monitor and new fitness features like Gym Connect and activity coaching. The tech giant is also working with researchers at Stanford Medicine to determine if the watch’s heart rate sensor can detect irregular heart rhythms.
The ubiquitous company has dropped clear hints of its interest in healthcare. Apple CEO Tim Cook told Fortune last year the company is “extremely interested” in the area, adding there is “a lot of stuff I can’t tell you about that we’re working on.”