Apple Watch AFib History Feature Qualified by FDA to Evaluate Medical Devices

Apple's atrial fibrillation (AFib) history feature on Apple Watch has been qualified by the FDA under its Medical Device Development Tools (MDDT) program, the first digital health technology feature of its kind to do so.

watchos 9 afib history
Since 2022, Apple Watch has supported AFib History, which allows users diagnosed with atrial fibrillation to view an estimate of how frequently their heart is in this type of irregular rhythm.

The feature analyzes pulse rate data collected by a photoplethysmography (PPG) sensor to identify episodes consistent with AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear). Apple says the feature is intended for individuals aged 22 years or older who have been diagnosed with atrial fibrillation.

The AFib History feature received FDA clearance in the United States just prior to its announcement by Apple, after being validated in a clinical study. The MDDT program under which the feature was approved today is the FDA's method of qualifying tools that medical device sponsors can choose to use in the development and evaluation of medical devices.

According to the FDA, the Atrial Fibrillation History feature is:

  • The first digital health technology qualified under the MDDT program, providing a non-invasive way to check estimates of atrial fibrillation (AFib) burden within clinical studies.
  • 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.
  • Designed to be used throughout the clinical study, both before and after cardiac ablation devices, to monitor a study participant’s weekly estimate of AFib burden.


Related Roundup: Apple Watch Series 9
Tag: FDA
Buyer's Guide: Apple Watch (Caution)

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Top Rated Comments

james yates Avatar
4 weeks ago
Never heard of atrial fibrillation until my watch told me I had it.,Thank you Apple, still here and going well.
Score: 26 Votes (Like | Disagree)
DelayedGratificationGene Avatar
4 weeks ago
Hmmm quiet. Where is everyone with the snarky zingers? Cant with this one as Amazing Apple is once again saving lives!
Score: 14 Votes (Like | Disagree)
ElvisThePelvis Avatar
4 weeks ago
I have a few AFIB attacks per year. The Emergency Room near my house takes my watch results quite seriously and it has been 100% in catching me in AFIB, validated at the hospital each time of course. I've gotten pretty good at recovery as well, my last AFIB attack was in October. I woke up in AFIB, alerted by my watch. From the first alert at 7 a.m. until treatment and Cardioversion at 11 a.m. my watch was consistently reporting with the medical equipment. That was the fastest attack to treatment I had experienced.

I appreciate the health features in the watch more than most I think.
Score: 11 Votes (Like | Disagree)
Godspeed8230 Avatar
4 weeks ago
That's really great.
Score: 8 Votes (Like | Disagree)
DelayedGratificationGene Avatar
4 weeks ago

Never heard of atrial fibrillation until my watch told me I had it.,Thank you Apple, still here and going well.
Awesome! All the best james
Score: 7 Votes (Like | Disagree)
murdoc2k Avatar
4 weeks ago
The health and watch team is crushimg it ?? This gives me hope that Apple is still the company that pushes boundaries for the greater good of humanity.
Score: 7 Votes (Like | Disagree)