Apple has always come up with a varied range of products from MacBook to iPods, from phones to watches. We all have heard how Apple had earlier struggled to get permission from the garner government for its Apple watch series 4 in which the electrocardiogram feature was added. With the launch of the latest model of Apple watch series 6 which has the added feature of blood oxygen monitor, this time it didn’t require them the FDA (Food and Drugs Administration) approval. This might be a little shocking to many as many may relate it to the medical field but Apple does not consider it as a medical feature.
According to The Verge, pulse oximeters are like the blood oxygen tracking feature in the Apple Watch is considered Class II Medical Devices, and documentation is generally required, but there’s a way around that too. If a pulse oximeter is marketed as being for general wellness rather than for a medical purpose, FDA documentation is not required. It is not intended for medical use rather for the general wellbeing of the user. The tracking provides no insight if your low on your blood oxygen or alert if your blood oxygen falls low. Apple has tried to pull up such a feature without much medical interference. As it’s not at all related to the functionality of the ECG. The ECG readings from the watch are used to alert users of abnormal heart rhythm.
Avoiding regulatory approval in the United States and other countries permitted Apple to launch the blood oxygen feature in more than 100 countries. ECG availability is still limited as it requires medical approval in each country it launches in. Which is indeed become a tedious task for a company like Apple. Due to this feature that has spread like wildfire all over the internet has also started to create great confusion in the minds of the people especially the health-conscious ones. As they compared the results of the oximeter and the watch they did find a difference. This could be misleading for many, but all the users should be well aware of it beforehand to avoid misunderstandings. With the advancement of technology, things will get better altogether. There is significant research being carried on of providing accurate results with the blood oxygen monitor.