FDA Greenlights ‘Atrial Fibrillation History Feature’ for Apple Watch Ahead of WWDC

BY Chandraveer Mathur

Published 6 Jun 2022

Apple Watch

The US Food and Drug Administration (FDA) has approved a new feature for the Apple Watch. According to filings released today, Apple is developing an advanced atrial fibrillation tracking feature for the wearable.

Presently, the Apple Watch ECG app can only detect atrial fibrillation characterized by an irregular heartbeat between 50 and 150 BPM. In some markets, the detection only works between 50 and 120BPM. However, with the recently-granted FDA approval, Apple will be able to provide Apple Watch users with an in-depth analysis of their afib condition.

Recently, Bloomberg’s Mark Gurman claimed that watchOS 9 would enhance the Apple Watch’s Afib detection capabilities. He said “Afib burden detection” would let users monitor how often they are in a state of atrial fibrillation during a specified period. The FDA filing reveals that the functionality would be baked into the wearable’s ECG app.

Apple claims the Apple Watch can classify an ECG recording as Afib or sinus rhythm with a specificity of 98.3 percent for the former and 99.6 percent for the latter. The company’s statistics were obtained through a clinical trial involving around 600 subjects.

The timing of the FDA approval leads us to believe it could be one of the major talking points during WWDC. However, Apple could also withhold the feature, so it debuts alongside the next-generation Apple Watch later this year.

The WWDC 2022 keynote address is set to commence in a few hours, chock-full of announcements about iOS 16, iPadOS 16, watchOS 9, and the next version of macOS. Check out the starting time in your time zone and how you can watch the event live.

[Via MyHealthyApple]