The Apple Watch 6 pulse oximeter doesn't have FDA clearance, here's why
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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.
The distinction between a feature used for wellness and one used for medical monitoring is important — one has been cleared by experts, and the other hasn’t. But those differences often aren’t clear to people buying a product like an Apple Watch, particularly when the marketing blurs the line — as Apple did when it directly compared the heart monitoring features on the watch to the new pulse oximeter. “A lot of times, patients and consumers don’t really understand the difference. So they’ll start using the device and relying on the information.