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Apple Watch is FDA's first-ever approved digital AFib history device

Apple Watch health features

The FDA has approved the Apple Watch's atrial fibrillation history feature under its stringent Medical Device Development Tools program that specifies what devices health professionals can rely on.

Apple Watch has had an atrial fibrillation feature since 2022, and the FDA approved its use just hours before Apple announced it. Since then, it has been credited with saving lives, including those of people who previously had no reason to suspect they had severe heart problems.

Now on top of its allowing the sale of the feature, the Food and Drug Administration has also passed the Apple Watch's AFib history feature for its Medical Device Development Tools (MDDT) program. As first spotted by MyHealthyApple, this makes the Apple Watch the first digital health technology to qualify under MDDT for a non-invasive way of estimating atrial fibrillation.

According to the FDA, the MDDT program is for it to "qualify tools that medical device sponsors can choose to use in the development and evaluation of medical devices."

Apple submitted the Apple Watch atrial fibrillation history feature to the FDA on December 21, 2023, according to an MDDT filing. As part of the application, Apple supplied data from a clinical study of 280 people where the Apple Watch's results were compared to a previously-qualified reference device.

"The average difference between the AFib History Feature and the reference device's weekly burden estimate was 0.67% with a 95% confidence interval of (-0.05%, 1.38%)," says the FDA filing. "92.9% (260/280) of subjects had paired weekly AFib burden differences within 5%; 95.7% (268/280) of subjects' weekly AFib burden estimates were within +10% of the reference."

Noting that medical device developers "have already incorporated [the Apple Watch]... within clinical studies," the FDA concludes that Apple's device qualifies for the MDDT program. However, because the Apple Watch does not identify atrial flutter or atrial tachycardia, the FDA says it is qualified "only as a secondary endpoint to compare estimates of AFib burden."

As well as specifically alerting many users to atrial fibrillation, the feature has led patients to be diagnosed with diabetes.