The Apple Watch series AFib feature has received new approval from the FDA. From now on, the results returned by the devices are considered medical grade. Previously, the results could be considered indicative.
AFib (atrial fibrillation) is a cardiac condition that produces abnormal heartbeat patterns. It causes irregular contractions of the heart in affected people, with peaks that exceed 400 beats per minute. Apple debuted the AFib monitoring function on its smartwatches in mid-2023. The feature is compatible with Apple Watch Series 4 onwards.
A feature related to something so delicate needs multiple certifications before being available. The FDA had given preliminary 510(k) clearance to Apple. A device or medical function with 510(k) certification means that it is “substantially equivalent” to other similar devices marketed in the United States. That is, it should be as safe and effective as other products marketed in the same segment.
FDA certified the Apple Watch series AFib monitor as a medical tool
Previously, the FDA preliminary granted clearance after verifying that legally marketed optical pulse oximeters were functionally equivalent to the system used by the Apple Watch to detect AFib patterns. The Galaxy Watch AFib monitor is sold in this condition. The same applies to the equivalent features of Fitbit and Google Pixel Watch devices.
Now, as reported by 9to5Mac, the Apple Watch AFib feature is getting MDDT approval. This one (an acronym for “Medical Device Development Tool”) guarantees that the results returned by the approved device or function are sufficiently accurate or reliable to be considered medical grade. More specifically, the AFib measurements from the Apple Watch are now “scientifically plausible” to the FDA. This means that the results can even be used for research studies related to AFib.
The latest FDA certification notes that the Apple Watch AFib feature is the “first digital health technology qualified under the MDDT program.” So, it can be used effectively to potentially determine this health condition. The measures or treatments to follow to control the condition can also be determined based on the measurements.
