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Apple Watch's sleep apnea notification feature granted FDA approval — and just in time for watchOS 11

Dave LeClair
2–3 minutes
(Image credit: Future)

Sleep apnea detection is one of the most remarkable new features coming to the new Apple Watch Series 10 , Apple Watch Series 9 and Apple Watch Ultra 2 . However, the feature came with an asterisk, with Apple requiring FDA approval before the feature could be used. Apple received approval, according to an entry on the FDA's website .

Apple says, "The feature will be supported on Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2. It is intended to detect signs of moderate to severe sleep apnea for people 18 years old or older without a diagnosis of sleep apnea."

According to the FDA, the sleep apnea detection feature on Apple Watch is "Substantially Equivalent" to an "Over-The-Counter Device To Assess Risk Of Sleep Apnea." Essentially, that means it functions similarly to a device designed for sleep apnea detection.

The approval was officially granted on 9/13/2024, but it took a little while to be posted. Apple submitted the request on 04/04/2024, so the feature has been in the works for some time.

Apple also noted that the feature will launch with watchOS 11 , officially hitting supported devices today (September 16). Again, the sleep apnea notification feature is only available on Apple Watch Series 10, Apple Watch Series 9, and Apple Watch Ultra 2, but there are plenty of other exciting features coming to WatchOS 11 that you can get excited about if you have an older device.

This is a developing story.

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Dave LeClair is the Senior News Editor for Tom's Guide, keeping his finger on the pulse of all things technology. He loves taking the complicated happenings in the tech world and explaining why they matter. Whether Apple is announcing the next big thing in the mobile space or a small startup advancing generative AI, Dave will apply his experience to help you figure out what's happening and why it's relevant to your life.

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