By Tim Hardwick
Apple's atrial fibrillation (AF) history feature on Apple Watch has been certified by the FDA under the Medical Device Development Tools (MDDT) program. This is the first digital health technology feature of its kind to prove this.
Starting 2022 Apple The Watch supports an atrial fibrillation history, which allows users diagnosed with atrial fibrillation to view an estimate of how often their heart experiences this type of irregular rhythm.
This feature analyzes heart rate data collected by the photoplethysmography (PPG) sensor to identify episodes consistent with AF and provides the user with a retrospective assessment of AF burden (a measure of the amount of time spent in AF while on Apple Watch) . Apple says the feature is intended for people aged 22 and older who have been diagnosed with atrial fibrillation.
The Atrial Fibrillation History feature received FDA clearance in the US shortly before Apple announced it after review. in a clinical study. The MDDT program, under which this feature was approved today, is the FDA's method for qualifying tools that medical device sponsors can use in the development and evaluation of medical devices.
According to the FDA, the Atrial Fibrillation History feature:
- The first MDDT-certified digital health technology providing a non-invasive way to validate estimates of the burden of atrial fibrillation (AF) in clinical settings. studies.
- Intended for use as a biomarker test to aid in the evaluation of atrial fibrillation burden assessment as a secondary efficacy endpoint in clinical trials designed to evaluate the safety and effectiveness of cardiac ablation. treatment devices.
- Intended for use throughout the clinical trial, both before and after cardiac ablation devices, to monitor the weekly assessment of the burden of atrial fibrillation in the study participant.
(Via MyHealthyApple.com.)
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