The Apple Watch has been a bit of a game changer for health and fitness, thanks to its ability to encourage people to move more, sleep longer, and sweat through Apple Fitness+ But the wearable made history as the first digital health technology device to receive FDA approval
The Atrial Fibrillation (AFib) feature, which utilizes an optical heart sensor in the Series 4 and above, has been approved as a certified device under the FDA's Medical Device Development Tools (MDDT) program This makes the Apple Watch the first digital health technology qualified for use as a "tool for evaluating burden estimates of atrial fibrillation (a type of arrhythmia, or abnormal heartbeat) in clinical trials"
If you are not familiar with atrial fibrillation, it is an irregular (and often rapid) heart rhythm in which the upper chambers of the heart beat out of sync with the lower chambers Atrial fibrillation can occur and subside, and while it is not always life-threatening, it can be very serious in some situations Proper treatment is necessary to prevent the possibility of stroke
Apple Watch users can use the device's heart sensor to detect pulse waves on the wrist If the watch repeatedly detects irregular rhythms suggestive of atrial fibrillation, the user is notified and the date, time, and heart rate are recorded in the Health app
Apple had previously received FDA "clearance" to include atrial fibrillation functionality in the Apple Watch in 2022, but it was not ready for use in clinical trials This clearance simply means that Apple was able to demonstrate that the atrial fibrillation feature works as well as other existing devices that check for atrial fibrillation
Last year, Samsung received the same clearance for its irregular heart rhythm notification feature on the Galaxy Watch 6
While something like the best Apple Watch or the best Samsung Watch is definitely a big step forward in managing our health, it goes without saying that if we have any concerns, we should consult a trained medical professional
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