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Here’s why the Apple Watch 6 blood oxygen sensor hasn’t received medical certification

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Unlike the electrocardiogram (ECG) feature, Apple has not requested FDA (Food and Drug Administration) approval for the blood oxygen sensor in Apple Watch Series 6. For ECG approval, the company spent years researching this feature in a smartwatch with various medical organizations, including Mayo Clinic. According to The Verge, the blood oxygen measurement function of the new Apple Watch is not required for certification, as the manufacturer positions it as a health support without claiming any therapeutic use. Thus, it turns out that Apple chose to simply specify this feature as an auxiliary function that does not differ from other smartwatch manufacturers, for example, Huawei or Garmin.

Michael Matheny, co-director of the Center for Health Improvement through Informatics at Vanderbilt University, said that the difference between the function used to maintain wellness and the function used for medical monitoring is that the former was not approved by experts, and the latter received all the necessary certification. Such differences are often misunderstood by buyers, especially when marketing blurs the lines – as Apple did. According to Matheny, the company directly compared the heart monitoring function to a pulse oximeter. He also noted that patients and users don’t really understand the difference. Thus, they will begin to use the device and rely on the information received.

 

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