FDA Qualifies Apple Atrial Fibrillation History Feature as an Medical Device Development Tool

The Apple Watch atrial fibrillation (AFib) history feature has been qualified by the FDA under its Medical Device Development Tools (MDDT) program.

According to the FDA, the Afib 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.

AFib, is responsible for about 130,000 deaths and 750,000 hospitalizations each year in the U.S. Up to 30% of cases go undiagnosed until life-threatening complications occur. Worldwide, about 33 million people have the condition.

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