FDA approves Apple Watch for AFib medical research

The FDA approved the Apple Watch's atrial fibrillation tracking feature as part of its rigorous Medical Device Development Tools program, which determines which devices healthcare professionals can rely on.

The Apple Watch has had an atrial fibrillation feature since 2022, and the FDA approved its use just hours before Apple announced it. He has since been credited with saving lives, including those who previously had no reason to believe they had serious heart problems.

In addition to approving the sale of this feature, the Food and Drug Administration has now approved the Apple Watch's AFib history feature for its Medical Device Development Tools (MDDT) program. As first discovered by MyHealthyAppleThis makes Apple Watch the first digital health technology to qualify for a non-invasive method of assessing atrial fibrillation according to MDDT.

According to the FDA, the MDDT program is designed to “qualify tools that medical device sponsors can use in the development and evaluation of medical devices.”

According to an MDDT filing, Apple submitted the Apple Watch's atrial fibrillation tracking feature to the FDA on December 21, 2023. As part of the application, Apple provided data from a 280-person clinical trial comparing the results of the Apple Watch to a previously qualified reference device.

“The average difference between the AFib History Feature and the reference device weekly strain estimate was 0.67% with a 95% confidence interval of (-0.05%, 1.38%),” the FDA filing states. “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 integrated [the Apple Watch]…within clinical trials,” the FDA concludes that Apple’s device qualifies for the MDDT program. However, because the Apple Watch does not detect atrial flutter or atrial tachycardia, the FDA says it “qualifies only as a secondary endpoint to compare estimates of AFib burden.”

Not only does the feature specifically warn many users about atrial fibrillation, but it has also led to patients being diagnosed with diabetes.