Why Apple needed the FDA to sign off on its EKG but not its blood oxygen monitor

During the announcement of the Apple Watch Series 6, the company heralded the newest element — a blood oxygen monitor — as an addition to its existing slate of health features.

“Apple Watch is already a powerful health tool with apps that measure heart rate and heart rhythm,” said Sumbul Ahmad Desai, Apple’s VP of health. “And now adding blood oxygen brings in another valuable health measurement to users.”

The features on the Apple Watch that track heart rate and heart rhythm, though, have a key difference from the blood oxygen monitor: the heart-tracking features are cleared by the Food and Drug Administration (FDA), and the oxygen monitor is not. Apple went through a long, extensive process to develop and validate an EKG feature so...

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