Home / Apple / Here’s why the Apple Watch Series 6 Blood Acid Sensor did not require FDA approval

Here’s why the Apple Watch Series 6 Blood Acid Sensor did not require FDA approval



Apple introduced the ECG functionality in the Apple Watch with the launch of the Apple Watch Series 4. And to offer this feature in the smartwatch, the brand had to get FDA approval. However, Apple did not need FDA approval to offer the blood oxygen monitor in the Apple Watch Series 6, and here’s why.

The Cupertino-based technology giant introduced the oxygen monitor in its blood in its smartwatch series with the launch of the Apple Watch Series 6. And considering that Apple had to get FDA approval to offer ECG functionality, some would think that the brand had to take approval from FDA to offer the function of oxygen monitoring in blood as well.

As it turns out, that is not the case. Apple did not seek FDA approval to offer a blood oxygen monitor in the Apple Watch Series 6. And The Verge, in its latest report, explains why the brand did not need to take FDA approval to offer this feature.

According to the publication, the oxygen monitor in blood is classified as a Class II medical device by the FDA. Any company that wants to sell an oxygen monitor for blood must submit documents to the health agency showing that their oxygen monitor works as well as other versions of the same product that are already on sale.

However, FDA guidelines also state that if a brand markets its oxygen monitor in the blood as a “wellness”

; device instead of a device to diagnose or treat a medical condition, it will not need to take clearance from the health authority to sell the device to the public. And that’s the route Apple took.

While the brand did not clearly state that the blood watch sensor in the Apple Watch Series 6 is a “wellness” device, it did not market it as a device to diagnose or treat a medical condition. So, technically, Apple is marketing the blood oxygen monitor in the Apple Watch Series 6 as a “wellness” device, which allowed it to offer the feature to the public without FDA approval.

So why did Apple take FDA approval for ECG? Could it not have marketed the ECG feature as a “wellness” device as well? No. The ECG functionality in the Apple Watch Series 4 is classified as a feature that can diagnose or treat a medical condition, by the FDA; it can not be classified as a “wellness” device, and therefore Apple had to approve the FDA to offer the ECG functionality. But the same was not the case with the oxygen monitor in the blood, and Apple could offer it without FDA approval.

What we do not know at the moment is whether Apple made the decision to market the oxygen monitor in the Apple Watch Series 6 to skip FDA approval, or if the brand really wants people to look at it as a “wellness” device. . Regardless, the oxygen monitor in the blood has become the need of the hour; it is an important device for diagnosing the COVID-19 virus. And the fact that the Apple Watch Series 6 has this feature, makes it a life-saving device, at least for the moment.

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Have you used the oxygen monitor in the Apple Watch Series 6? If so, have you found it accurate? Let us know your thoughts in the comments section below.

[Source: The Verge]