Here's Why the Blood Oxygen Sensor in Apple Watch Series 6 Didn't Require FDA Approval

Apple introduced the ECG functionality in Apple Sentinel with the launch of the Apple tree Watch Serial 4. And to offer this feature in the smartwatch, the make had to accept approval from the FDA. However, Apple didn't have to have approval from the FDA to offer the blood oxygen monitor in the Apple Scout Series six, and hither is why.

The Cupertino-based tech giant introduced the blood oxygen monitor in its smartwatch lineup with the launch of the Apple Watch Serial 6. And because that Apple tree had to take approving from the FDA to offer the ECG functionality, anyone would think that the brand had to take approval from the FDA to offer the blood oxygen monitoring feature equally well.

As information technology turns out, that isn't the example. Apple tree didn't have to take approval from the FDA to offering a blood oxygen monitor in the Apple Watch Series half-dozen. And The Verge, in its latest written report, explains why the make didn't have to have FDA approving to offer this feature.

According to the publication, the blood oxygen monitor is classified every bit a Course II medical device past the FDA. Any visitor that wants to sell a blood oxygen monitor needs to submit documents to the wellness agency proving that their blood oxygen monitor works as skillful equally other versions of the aforementioned product that are already on sale.

However, FDA'southward policies as well say that if a brand markets its blood oxygen monitor as a "wellness" device rather than a device to diagnose or treat any medical status, information technology will not have to accept any clearance from the health agency to sell the device to the public. And that is the route that Apple took.

While the brand didn't clearly say that that the blood oxygen sensor in the Apple Watch Series vi is a "wellness" device, it didn't market place information technology as a device to diagnose or care for a medical status either. And then, technically, Apple is marketing the blood oxygen monitor in the Apple tree Picket Series 6 as a "wellness" device, which allowed it to offer the feature to the public without taking approval from the FDA.

And so why did Apple take an FDA approval for ECG? Could it not take marketed the ECG feature equally a "wellness" device as well? Nope. The ECG functionality that is in the Apple Lookout man Series four is classified every bit a feature that can diagnose or treat a medical status, by the FDA; information technology cannot be classified as a "wellness" device, which is why Apple had to take an approving from the FDA to offer the ECG functionality. But the aforementioned wasn't the case with the blood oxygen monitor and Apple could offer it without an FDA approval.

What we don't know at the moment is if Apple took the decision to market the blood oxygen monitor in the Apple Lookout man Serial vi to skip getting approval from the FDA or if the brand truly wants people to run into it equally a "health" device. Whatever the case, the blood oxygen monitor has become the need of the hour; it is an essential device to diagnose the COVID-19 virus. And the fact that Apple Watch Series 6 has this feature, makes information technology a life-saving device, at least at the moment.

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Have you lot been using the blood oxygen monitor in the Apple Watch Series 6? If yes, have you lot plant information technology to be accurate? Do let usa know about your thoughts in the comments section beneath.

[Source: The Verge]