In a significant development for digital health technology, the atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first to be qualified under a program recently introduced by the FDA. This program, known as the Medical Device Development Tools (MDDT) framework, aims to reduce the regulatory burden of evaluating new technologies and speed up the review process.

The FDA has recognized the Apple Atrial Fibrillation History Feature, a non-intrusive method for assessing AFib load estimates, as a biomarker test now qualified for use as a secondary efficacy endpoint in clinical trials. AFib is an irregular heartbeat condition where the heart’s upper chambers fail to synchronize with the lower ones. It affects around 2% of people under the age of 65 and 9% of those who are older. 

Apple’s software uses artificial intelligence to regularly check heart rhythms for signs of AFib and provides an estimate of how often a patient’s heart is beating irregularly while wearing an Apple Watch.

The MDDT certification encompasses its application in research aimed at assessing the safety and efficacy of cardiac ablation instruments utilized for AFib treatment. However, it could also apply to other studies where there is a need to provide an estimate of how long people have AFib over time.

In a 400,000-subject study of the Apple Watch’s ability to detect irregular heart rhythms that may signal AFib, it was found that 34% of individuals who received a notification of arrhythmia were later found to have AFib using an ECG, with a positive predictive value for the AI of 84%.

This advancement signifies a major leap in the application of wearable devices for health surveillance, and it holds the potential to preserve lives by enabling the early identification of cardiac disorders. The detection feature was approved by the FDA in 2022, and the history feature covered by the MDDT qualification is set to be released in the fall of 2022.