Re:Apple Watch no longer sold with blood oxygen monitoring a...
by mslip1 on Sunday January 21, 2024 @09:28PM
(#39085393)
I believe the Apple Watch is a class 2 medical device because it alerts you if it thinks you’re having a heart attack. They probably got a 510k for this and based it on some other predicate device
The FDA doesn't regulate "over the counter" oxygen sensors (including those you find at a CVS or Walgreens), but that study suggests that if they did, Apple could get an FDA clearance. They already have several FDA clearances for the Apple Watch's ECG, irregular rhythm notifications, and afib history features.
The oxygen sensor is helpful for detecting, among other things, sleep apnea, where 60-80% of people are undiagnosed.