Apple gets FDA okay to use AFib tool in clinical trials

David Švihovec

The atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first digital health technology to be qualified under a programme recently introduced by the FDA designed to encourage the development of medtech.

The US regulator published guidance on the Medical Device Development Tools (MDDT) framework last year, a voluntary process that aims to reduce the regulatory burden of evaluating new technologies and speed up the review process.

The approach covers a range of products, including biomarker tests, clinical outcome assessments, and non-clinical tests, and provides an endorsement that the data supports their safety, effectiveness, or performance.

The FDA notes that the Apple Atrial Fibrillation History Feature – which provides a non-invasive way to check estimates of AFib burden – has now been qualified as a biomarker test that can be used as a secondary effectiveness endpoint in clinical studies.

AFib is a type of irregular heart rhythm (arrhythmia irregular heart rhythms) where the upper chambers of the heart beat out of sync with the lower chambers, and affects around 2% of people under the age of 65 and 9% of those older, according to Centres for Disease Control and Prevention (CDC) data.

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

Specifically, the MDDT qualification covers its use within studies intended to evaluate the safety and effectiveness of cardiac ablation devices used to treat AFib, but in principle 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, published in 2019, 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%.

Apple has also reported anecdotal incidences of Apple Watch users receiving a warning of arrhythmia that has prompted them to seek medical advice, potentially saving their lives. The detection feature – not the history feature covered by the MDDT qualification – was approved by the FDA in 2022.

Photo by David Švihovec on Unsplash