FDA Gives Apple Watch’s AFib-Tracking App Go-Ahead For Clinical Studies

Clinical trials will now be able to make use of the Apple Watch’s atrial fibrillation monitoring capabilities as a result of the Food and Drug Administration’s (FDA) landmark approval.

The sensor and software of the watch have helped it become the first digital health device to be recognized under the agency’s Medical Device Development Tools program. This program is a voluntary route that recognizes some technologies as being dependable enough to be used in scientific study without the need for further evaluation.

The program has already granted the go-ahead to a variety of tools, including imaging systems that assist in screening for patients who may be suitable for a study and cardiovascular disease surveys for assessing quality of life.

The Apple Watch is now included on the list of biomarker tests that may assist in estimating the burden of atrial fibrillation (AFib) on a patient as a secondary efficacy goal. This can be done, for example, after the patient has had a cardiac ablation surgery to repair the abnormal heart rhythm.

Apple’s software, which they have dubbed AFib History, is designed to provide a long-term perspective on the period of time that the heart diverges from its normal rhythm. The wearer’s heartbeat is monitored on a regular basis, and the results are graphed alongside other data, such as the amount of sleep, exercise, and alcohol intake that has been logged. The software does not send out notifications on specific bouts of AFib; rather, it sends out a report once a week.

The application is intended for individuals who have already been diagnosed with atrial fibrillation and are at least 22 years old. Additionally, the watch must be worn for a minimum of 12 hours each day for a period of five days. The FDA previously gave its approval to the program in June 2022.

The FDA stated the following regarding the news, “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.”

Now, the creators of cardiac ablation treatments and advertisers of studies will no longer be required to provide the FDA with justifications for its data collection methods. For instance, there will be no need to go into any detail about why they decided to use a device like a wearable Holter for, say, six months.

Apple has long presented its watch as a wearer’s lifeline. It has been said that some features, such as fall and auto accident detection, have helped to saved lives.