There is no doubt that the oxygen saturation measurement in the Apple Watch Series 6 has been one of the characteristics that has stood out the most of this new watch. The problem is that many had in mind that they would not be able to use it due to the sanitary regulations that always exist around functions like this. Without going any further, this already happened when the ECG function was presented, but this time the situation is quite different.
New Apple Watch sensor does not require FDA approval
As we mentioned, the possibility of performing electrocardiograms that arrived in the Apple Watch Series 4 could not reach all countries at the same time. This is because it is necessary to receive approval from the medical authorities in each of the countries where it is intended to be used. From the outset, it was only approved by the FDA, the US agency, and the approval of the rest of the agencies was arriving over time, such as the European one.
In the case of oxygen saturation measurement a totally different situation has arisen. It has been able to reach all users at once as no approval is required from medical authorities. This is because it has been categorized as a sensor related to the well-being of users and in no case as a medical sensor. The fact that no type of diagnosis is made by the measurement application is enough for it not to go through a medical sensor.
This does not happen with the ECG function, since in addition to showing the electrocardiogram, it also gives an interpretation of these, such as cardiac fibrillation. Although it is recalled on numerous occasions that this result is not definitive, the fact that it is, requires this approval which is making it difficult to reach many countries. This is why the oximeter by not detecting any type of disease or giving any verdict of the result can pass this approval from the FDA or the rest of the agencies. Obviously, this data can be interpreted by users, but especially by health professionals to make a pathological picture.
The oximeter does not detect disease
This information in itself is really interesting, since it reminds you that the measurement of oxygen saturation does not detect any type of disease as such. This is an idea that unfortunately has been generalized in certain users who have seen this sensor as a door to diagnose diseases in a solitary way. It should be based on the premise that it does not have absolute precision and that these data always have to be interpreted by people specialized in diagnosis with a complete medical history. And as with the ECG function, the angular test to determine this oxygen saturation is an arterial blood gas. This information that has been provided today leads to the elimination of these ideas that considered the new sensor as an official medical device.
