The FDA has qualified the Apple Watch’s Atrial Fibrillation (AFib) history feature in the US, which “opportunistically analyses pulse rate data collected by the general-purpose Apple Watch photoplethysmography (PPG) sensor” to identify episodes of irregular heart rhythms, for use in clinical studies.
The Watch has qualified as part of the FDA’s Medical Device Development Tools (MDDT) program, which is intended to support medical device development and timely evaluation, and promote innovation by qualifying tools “that medical device sponsors can choose to use in the development and evaluation of medical devices”.
The FDA’s announcement highlighted the Apple Watch feature as “the first digital health technology qualified under the MDDT program”, and its use “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”; as well as its use throughout clinical studies to monitor weekly estimates of “AFib burden”.
In the FDA’s published summary of evidence and basis of qualification, evidence to support the qualification of the Apple Watch’s AFib feature includes an evaluation using data from two cohorts, with a total of 280 subjects; one cohort with non-permanent AFib, and one with permanent AFib. According to the findings, the performance data demonstrates “the effectiveness of the AFib History Feature to provide clinically acceptable retrospective weekly AFib burden estimates, thus meeting the objective qualification criteria for the AFib History feature as a biomarker test”.
The summary also notes that the feature’s failure to provide “specific time stamps”, ventricular rate, and length of episodes for AFib patients, as well as to identify “atrial tachyarrhythmias other than AFib”, “underlies the qualified use of the tool as only a secondary endpoint to compare estimates of AFib burden”.
To learn more about the FDA’s decision, please click here.
Also from the US, Emory Healthcare has announced its deployment of the Epic electronic health record, with MacBook Airs made available to thousands of clinicians to support accessing of patient records via the platform.
