The Blubber

Apple, $AAPL, has received FDA approval for Sleep Apnea Detection on the Apple Watch.

Sleep apnea detection is among the standout new features introduced with the Apple Watch Series 10, as well as last year's Apple Watch Series 9 and Apple Watch Ultra 2.

When first announced, the feature came with a caveat: Apple had not yet secured FDA approval for its use. However, Apple has now received approval just before the launch of watchOS 11, according to an FDA entry published on September 16.

According to Apple's Newsroom, the feature "is designed to identify signs of moderate to severe sleep apnea in individuals aged 18 and older who have not been diagnosed with the condition." This means it’s not a definitive diagnosis but a preliminary detection that can prompt users to consult a doctor for further evaluation.

The FDA has classified the sleep apnea detection feature as "Substantially Equivalent" to an "Over-The-Counter Device To Assess Risk Of Sleep Apnea," indicating that it operates similarly to existing sleep apnea detection devices.

The approval was granted on September 13, 2024, following Apple’s submission of the request on April 4, 2024, showing that the feature has been in development for some time.

However, not all Apple Watch users will have access to this feature. It will be available only on the Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2, despite being integrated into watchOS 11, which is compatible with Series 6 and newer models.

watchOS 11 officially launches today (September 16), and while the sleep apnea detection feature is exclusive to the Series 9, Series 10, and Ultra 2, there are many other exciting new features in watchOS 11 for those with older devices to look forward to.