- The Food and Drug Administration has cleared AliveCor’s KardiaBand app for use with Apple Watch, the company announced Thursday. The app is the first medical device accessory for Apple Watch to get FDA’s green light, AliveCor said.
- The app lets Apple Watch users capture a 30-second EKG to detect normal heart rhythms and atrial fibrillation, the most common heart arrhythmia. Results are displayed on the watch.
- The Mountain View, Calif.-based company is also launching SmartRhythm, an artificial intelligence-based feature of the KardiaBand app that monitors both heart activity and physical activity. When the two are out of sync, the device alerts users to take an EKG with KardiaBand or KardiaMobile, AliveCor’s portable EKG reader.
The regulatory clearance could be a boost for use of Apple Watch as a medical device.
Apple is one of nine companies the FDA recently selected to participate in its digital health software precertification pilot program. The program — part of the agency’s effort to foster innovation of digital tools — aims to review software developers, rather than their products, to determine if they meet quality standards and should be precertified.
The tech giant has been adding more health features to Apple Watch and exploring more medical uses. The Apple Watch Series 3, OS4, debuted in September, includes an enhanced heart monitor and new fitness features like Gym Connect and activity coaching. Apple is also working with Stanford Medicine researchers to see if the watch’s heart rate sensor can detect irregular heart rhythms.
The KardiaBand app for Apple Watch has huge potential, but faces some barriers to adoption. At $199 plus a $99 annual subscription to AliveCor’s Premium service, KardiaBand could be out of reach for people living on modest and lower incomes. Those same people may see Apple Watch as a too-pricey commodity, reducing the population that would benefit from the app.