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

Unlike what it did with the , Apple didn't seek FDA approval for the . 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 .

Thus, ...

Thursday, 8 October 2020 GSM ARENA GSMArena.com