The great novelty of the Apple Watch Series 6 is the possibility of measuring your blood oxygen, however Apple ensures on its website that this device is not certified by the FDA, why?
When Apple introduced the Apple Watch Series 4 and its most important feature, the electrocardiogram (ECG), boasted of having the approval of the FDA (Food and Drug Administration) of the United States, the body that regulates all medical devices and drugs in the country, which means that the device is reliable. However, for the pulse oximeter, the sensor that determines the oxygen saturation in our blood, this has not been the case. Why hasn't Apple sought FDA approval in this case? Does this mean that the pulse oximeter is unreliable?
The explanation is simple: to get FDA approval it is necessary to present clinical trials whose results support that your device complies with what you claim. Apple claimed that its Apple Watch Series 4 (and later Series 5 and 6) could diagnose Atrial Fibrillation using the ECG, and that had to prove it with studies that supported it. Nevertheless Apple has not said anything about the pulse oximeter of the Apple Watch Series 6, there is no disease that it can diagnose, and here's the "trick" why you didn't need FDA approval to get it on your smartwatch.
But this does not mean that this oxygen sensor does not work well, far from it. In fact Apple is working in collaboration with various universities and medical institutions to demonstrate that the Apple Watch Series 6 oxygen monitor can detect abnormalities or even help diagnose diseases in very early stages, such as Flu or COVID-19. If these studies conclude that what Apple maintains is true, the pulse oximeter in the Apple Watch could gain FDA approval later.
Simple because it is the same as masks there is no business and they realize that little by little technology is eating ground and in the future we can do our own Health controls