FDA

FDA qualifies Apple Watch AFib history feature for use in clinical trials

May 8, 2024

FDA announced the Apple Watch atrial fibrillation (AFib) tool is qualified for use in clinical trials through its Medical Device Development Tools (MDDT) program, allowing researchers to use the feature to detect arrhythmias. Apple Watch’s tool is the first digital health technology qualified under the FDA’s MDDT program, which is aimed at evaluating devices for use in medical research.

Apple’s tool monitors changes in blood flow at the wrist and measures intervals between heart beats, and the history feature analyzes the intervals to estimate the amount of time the wearer spent in AFib over the previous week.

FDA’s announcement describes the Apple AFib feature as a noninvasive way to collect data prior to and after treatment, stating it is “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.”

The FDA previously granted clearance to two Apple Watch functions as a direct-to-consumer wearable device with an electrocardiogram and to notify the wearer if an irregular heartbeat was detected.

Sources:

(2024, May 1). U.S. Food & Drug Administration. FDA qualifies Apple atrial fibrillation history feature as an MDDT. [News bulletin]. https://content.govdelivery.com/accounts/USFDA/bulletins/399d551

(2024, May 1). U.S. Food & Drug Administration. Medical Device Development Tools (MDDT). https://www.fda.gov/medical-devices/medical-device-development-tools-mddt

Taylor, NP. (2024, May 6). MedTech Dive. FDA qualifies Apple Watch AFib feature for use in clinical trials. https://www.medtechdive.com/news/fda-apple-watch-atrial-fibrillation-medical-device-development-tool/715210/