The Apple Watch has been a bit of a game-changer for health and fitness thanks to its ability to push people to move more, sleep longer and break a sweat with Apple Fitness+. But the wearable has just made history as the first digital health tech device to receive FDA approval.
The atrial fibrillation (AFib) feature utilized through the optical heart sensor on Series 4 and above has received its approval as a qualified device in the FDA's Medical Device Development Tools (MDDT) program. This makes the Apple Watch the first digital health technology to qualify for use as a "tool to assess atrial fibrillation (a type of arrhythmia, or abnormal heartbeat) burden estimates within clinical studies."
If you're not familiar with atrial fibrillation, it's an irregular (and often, rapid) heart rhythm where the heart's upper chambers are beating out of sync with the lower ones. While AFib can come and go, and isn't always life threatening, it can be very very serious in some circumstances. It's a serious medical condition and requires proper treatment to prevent the possibilities of a stroke.
Apple Watch users can employ the device's heart sensor to detect the pulse wave at the wrist — and it will look for variability in beat‑to‑beat intervals while the wearer is, according to Apple, "at rest." If the watch repeatedly detects an irregular rhythm suggestive of AFib, users will receive a notification and the date, time, and beat‑to‑beat heart rate will be recorded in the Health app.
From 'cleared' to 'approved'
Apple had previously received FDA "clearance" to include the AFib feature in the Apple Watch back in 2022, but it was by no means ready to be used in clinical trials. The clearance simply meant Apple was able to demonstrate that its AFib feature worked similarly to other existing devices that check for the condition.
Last year, Samsung achieved the same clearance for its Irregular Heart Rhythm Notification feature found on the Galaxy Watch 6.
The likes of the best Apple Watch and best Samsung Watch are undoubtedly a huge step forward in managing our health, but it goes without saying that if you have any concerns you should still consult with a trained medical professional.
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