Apple Watch’s AFib Tool Gets FDA Approval

AppleWatch’s Atrial Fibrillation (AFib) detection feature.

Image credits: Apple

In a significant development for digital health technology, the atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first to be qualified under a program recently introduced by the FDA. This program, known as the Medical Device Development Tools (MDDT) framework, aims to reduce the regulatory burden of evaluating new technologies and speed up the review process.

Related FDA Clearance for Apple Watch App for Parkinson’s Disease

The FDA announcement describes using it as a noninvasive way to collect the data both before and after treatment:

“Designed to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices to treat.”

Apple has long marketed its watch as a lifesaver for its wearers. It has been said that certain features, like fall and auto accident detection, have saved lives. In its marketing, Apple frequently uses user testimonials from Apple Watch wearers who say they saw their doctors after getting heart-related notifications on their wrists, which may have saved their lives. However, added anxiety from extra data could also be detrimental, reports The Verge.

Two Apple Watch models—the Series 4 in 2018—were initially approved by the FDA to be sold directly to consumers as wearables that may provide an ECG and alert users to an irregular heartbeat. Additionally, it stated that the applications are "not intended to replace traditional methods of diagnosis or treatment" and that you should still see a licensed physician if you feel unwell or have any questions. According to one study, the treatments for certain disorders may not be appropriate for the average Apple Watch wearer, and the watch itself cannot diagnose ailments.

Sam Draper
May 14, 2024

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