The FDA has handed a groundbreaking green light to the Apple Watch, allowing its atrial fibrillation tracking features to be employed in clinical studies.
The watch’s sensor and software marked the first digital health product to be qualified under the agency’s Medical Device Development Tools program—a voluntary pathway that deems certain technologies as reliable enough to be employed in scientific research without needing additional review.
The program has previously given the thumbs-up to cardiovascular disease questionnaires for measuring quality of life as well as imaging programs that help screen for patients who may be eligible for a study, among other tools.
Now, the Apple Watch joins the list as a biomarker test that can help estimate a patient’s burden of afib as a secondary effectiveness endpoint, such as after undergoing a cardiac ablation procedure to correct the irregular heart rhythm.
Dubbed AFib History by Apple, the software aims to offer a long-term view into the amount of time the heart falls out of sync. It periodically checks the wearer’s heartbeat and graphs its findings alongside measures of sleep, exercise and logged alcohol consumption. The program does not provide alerts to individual afib episodes but instead delivers a weekly report.
The app is designed for people ages 22 and over who have already been diagnosed with afib and requires the watch to be worn for at least 12 hours a day for five days. The program was previously cleared by the FDA in June 2022.
According to the FDA, “The AppleAFib History Feature can help address the challenges of patient compliance, potential placebo effects, and the technical difficulties without an implantable device by allowing for passive, opportunistic AFib burden estimation in a wearable form that is already familiar to Apple Watch users.”
At the same time, developers of cardiac ablation therapies and sponsors of clinical trials will no longer have to provide the FDA with rationales for its data collection methods and cadence—for example, explaining why they chose to use a device such as a wearable Holter monitor for a period of six months.