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Here's why Apple didn't need FDA clearance for Apple Watch Series 6 blood oxygen sensing

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While Apple went to great lengths to garner government approval for Apple Watch Series 4’s ECG feature, the company didn’t do the same for a blood oxygen monitoring function on Apple Watch Series 6. Here’s why.
While Apple went to great lengths to garner government approval for Apple Watch Series 4’s ECG feature, the company didn’t do the same for a blood oxygen monitoring function on Apple Watch Series 6. Here’s why. When the ECG feature was introduced on the Apple Watch Series 4, Apple made note that it navigated a lengthy approval process to gain clearance from the Food and Drug Administration. As is typical in the consumer electronics industry, the blood oxygen feature on the Series 6 doesn’t have similar certifications. According to The Verge, that’s because pulse oximeters, also known as blood oxygen monitors, are in a different FDA classification. As long as a company doesn’t claim that the devices can diagnose diseases, it can sell one in the U.

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