Saturday, June 22, 2024

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.

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.

(Via Roundup: Apple Watch Series 9Tag: FDABuyer’s Guide: Apple Watch (Neutral)
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