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Why isn’t Apple Watch’s blood oxygen feature FDA-approved?

Answer: Because it doesn’t need to be.

Apple iWatch
Shutterstock/sergey causelove
When Apple released the fourth iteration of its Apple Watch, it added an EKG feature capable of detecting irregular heart rhythms typical of a condition known as atrial fibrillation. It said that users could rely on this feature to tell them if they might be showing early warning signs of this condition. This feature of the watch has been cleared and approved by the federal Food and Drug Administration (FDA).

This fall the tech giant announced the release of the sixth version of the Apple Watch. In addition to that FDA-approved AKG feature, Apple Watch 6 also comes with a pulse oximeter or blood oxygen monitor that does not carry FDA approval. So what’s the difference?

As it turns out, technology that comes with health features like these only need FDA approval for said features if they are designed to be used for a medical purpose. If, however, they are simply a general “wellness” feature, they don’t need FDA approval. Apple’s EKG feature was designed and marketed as a tool for monitoring for medical conditions, so it had to be medical grade and be approved as such. But the pulse oximeter is just for fun, only to be used as a source of information and not a tool of diagnosis. As long as Apple only markets it as such, there’s no need to go through the FDA approval process before selling to consumers.