New Series 6 Apple Watch（$399) tests blood-oxygen levels, but wh

but what does the FDA say?

https://www.marketwatch.com/story/worried-about-covid-19-new-399-apple-watch-tests-blood-oxygen-levels-other-products-do-this-for-17-but-what-does-the-fda-say-11600249690

 

Health was clearly on the minds of the designers behind the new Series 6 Apple Watch .

Sleep motion sensors, hand-washing detection and a blood-oxygen sensor are all functions of the new model unveiled Tuesday, which has a $399 starting price tag.

But the blood-oxygen sensor has garnered the most attention. 

“The new health sensor in Series 6 shines red and infrared light onto your wrist and measures the amount of light reflected back. Advanced algorithms use this data to calculate the color of your blood, which indicates the amount of oxygen present,” Sumbul Desai, vice president of health at Apple and a practicing doctor, said atTuesday’s event. “The new blood oxygen app lets you take a measurement in just 15 seconds.”

Apple is not marketing the new function of the watch as a medical device, that’s because it doesn’t currently have the U.S. Food and Drug Administration’s approval to do so.

“Blood Oxygen app measurements are not intended for medical use, including self-diagnosis or consultation with a doctor, and are only designed for general fitness and wellness purposes,” reads a product disclaimer for the Series 6 Watch. 

For instance, the FDA previous said that electrocardiogram readings, or ECGs, that aim to notify users of irregular heart rhythms, should not replace traditional diagnostic methods.

(Apple did not respond to MarketWatch’s inquiry.)

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