Will Apple receive any new FDA clearance by the end of 2023?
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resolved Jan 1
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NO

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@deagol Haha it’s not. I didn’t realize I created it twice! My bad. That other account is an alt I use for work.


As part of the FDA clearance process for the EKG, Apple had to provide and publish data showing that the feature could, in fact, flag atrial fibrillation. Doctors and experts were able to examine the information, and there are dozens of published research studies closely examining how well the watch can actually detect dangerous heart rhythms. Because the pulse oximeter is just a wellness product, though, Apple didn’t have to publish any of that information. When Matheny went looking for data showing how well the Apple Watch’s pulse oximeter worked compared to other devices on the market, he wasn’t able to find much. “It was concerning to me,” he says. Anecdotal reports from people testing the Apple Watch found that the pulse oximeter feature isn’t accurate and can be hard to use(https://www.theverge.com/2020/10/7/21504023/apple-watch-ekg-blood-oxygen-fda-clearance)

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