Sleep Apnea Feature in Apple’s Latest Smart Watch Gets FDA Approval

The U.S. Food and Drug Administration (FDA) has granted approval for sleep apnea detection on the Apple Watch Series 9, Series 10, and Watch Ultra 2, as announced on Monday. This approval comes just four days before the official release of the Series 10 on September 20.

This new feature, revealed at the recent iPhone 16 event, will be included in the upcoming watchOS 11 update.

To function, it requires users to track their sleep for at least 10 nights within a 30-day period. During this time, the watch also monitors nightly sleep disturbances using its built-in accelerometer.

Classified by the FDA as an “over-the-counter device to assess the risk of sleep apnea,” Apple emphasizes that the feature is not intended to provide a diagnosis.

Apple Watch Series 9

Instead, it is designed to alert users to the possibility of sleep apnea and encourage them to consult a healthcare professional for further evaluation.

Sleep apnea, which can cause intermittent pauses or shallow breathing during sleep, is linked to a range of symptoms, including insomnia, headaches, daytime fatigue, and more serious long-term health issues, according to the Mayo Clinic.

Apple is not the first to introduce sleep apnea detection in consumer electronics. Withings has offered this capability for some time, and Samsung recently gained FDA approval for the feature on its Galaxy Watch series.

Interestingly, the sleep apnea detection feature comes as another capability — blood oxygen monitoring — remains disabled on Apple Watches in the U.S. due to an ongoing patent dispute.

Jackson Kelley
Jackson Kelley
Jackson is a political activist and market expert. He covers the impact of politics on the market and global economy.
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