The Apple Watch’s ability to detect atrial fibrillation (AFib) is one of its most celebrated life-saving features, and multiple studies have shown it’s amazingly accurate. Now, the US Food and Drug Administration (FDA) is adding its voice to the chorus.
While the Apple Watch has long been FDA-approved for its ECG and other heart rate monitoring features, most recently expanding to support the new AFib History feature in watchOS 9, that’s a relatively low bar. The Apple Watch wasn’t even the first device to provide AFib detection — it was merely the most popular.
However, the FDA has now raised the Apple Watch to a significantly higher level by qualifying its Atrial Fibrillation History feature as a Medical Device Development Tool (MDDT).
This makes the Apple Watch the first digital health device to receive certification under the MDDT program, qualifying it to be used in clinical studies “to monitor a study participant’s weekly estimate of AFib burden.
The Apple Watch is listed in the “Biomarker Test” category, which the FDA describes as “a test or instrument [that can be] used to assess risk, or identify safety concerns, or predict treatment outcomes in patients.” It’s also the only heart-rate monitoring device in this MDDT category; the other certified Biomarker Test device is a software module designed to classify brain contusions.
What This Means for You
While the FDA’s new MDDT qualification won’t mean much directly for Apple Watch users, it’s a stamp of approval on how well the AFib History feature works and should inspire additional confidence that everyday users can rely on it.
The addition of ECG and AFib detection on the Apple Watch Series 4 was a landmark development in heart health. Atrial fibrillation is a relatively common but intermittent heart condition that often goes undiagnosed for years because it can only be detected when it’s actually happening.
According to the CDC, approximately 2% of people younger than 65 years old and 9% of people 65 and older have AFib. Irregularities in heart rhythm become more common as people get older. Some individuals with AFib don’t experience any symptoms. Others experience symptoms that could include rapid heartbeat, palpitations, fatigue, or shortness of breath.
Apple
Before the Apple Watch, detecting AFib was often a matter of luck. If you had this condition and your heart just happened to be in atrial fibrillation when your doctor was examining it, then you might get a proper diagnosis. Otherwise, it could fly under the radar for years.
However, most people wear their Apple Watch all day — and sometimes even to bed for sleep tracking. This means it’s in a much better position to detect AFib when it happens. While the Apple Watch doesn’t go so far as to make a diagnosis, it does warn folks that they should see their doctor when it detects an irregular heart rate rhythm that’s symptomatic of AFib.
In 2022, Apple added an AFib History feature that expanded the warnings of potential atrial fibrillation to also record the frequency with which it happens. Not everyone who experiences AFib encounters these irregular heart rhythms with the same frequency, so being able to track how often AFib occurs — known as an “AFib burden” — can determine how serious the condition is.
AFib History is intended to be used only by those who have actually been diagnosed with AFib by a doctor to help provide greater insight into the severity of the condition. It’s this aspect of the Apple Watch that the FDA’s MDDT qualification centers on since the agency has determined that it provides “scientifically plausible measurements” that can be used in clinical studies to determine the best treatments for AFib.