The Apple Watch 6 pulse oximeter doesn’t have FDA clearance, here’s why

The Apple Watch 6 pulse oximeter doesn't have FDA clearance, here's why

Unlike what it did with the electrocardiogram (ECG) function on its Watch series, Apple didn’t seek FDA approval for the pulse oximeter on the new Watch 6. In order to have its devices approved for the ECG feature, Apple spent years researching possibilities for this to happen with a humble smartwatch and artificial intelligence learning together with US healthcare staples like the Mayo Clinic.

The pulse ox function, on the other hand, can skate away with having to undergo a Class II device approval at the FDA by not claiming any therapeutic uses of the feature, and Apple simply marketing it as a “wellness” function, reports the Verge.

Thus, instead of having to prove that the pulse oximeter on the Apple Watch 6 works at least as good as other such devices to gain FDA clearance, Apple preferred to simply list the option as an auxiliary feature, no different than the approaches other smartwatch makers like Huawei or Garmin use for their own pulse ox meters.
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Needless to say, Apple’s Watch 6 will be more popular than all other such devices in the US, and there might soon be a critical mass of participants for enough studies and research on the health aspects of the pulse oximeter. Still, according to Michael Matheny, co-director of the Center for Improving the Public’s Health through Informatics at Vanderbilt University: 

Source: Phonearena


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