Apple Watch gets FDA approval for new sleep apnea detection

Jason Hiner/ZDNET

Apple's new sleep apnea detection has won official approval from the FDA just ahead of the release of WatchOS 11. The FDA notification, as spotted by TechCrunch, means that the agency has reviewed the safety and effectiveness of the feature and determined that the potential benefits outweigh any potential risks.

The approval comes at just the right time. Apple is due to release the new versions of its respective operating systems today, including iOS 18 and WatchOS 11, both of which are required to take advantage of sleep apnea tracking. The feature will be accessible only on the Apple Watch Series 9, Series 10, and Watch Ultra 2. The Series 10 is available now for preorder and will hit stores this Friday, September 20.

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Sleep apnea is a potentially serious condition in which your breathing periodically stops and restarts throughout the night. Since the disorder prevents your body from getting enough oxygen, untreated cases can lead to an increased risk of hypertension, cardiac issues, and even death.

At-home tests are available to detect the issue. But the tests are often expensive. Some require that you wear a mask. Others demand a doctor's prescription. The sleep apnea detection built into WatchOS 11 and a supported Apple Watch is less intrusive and easier to set up.

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In its notification, the FDA defines the feature as follows:

An over-the-counter device to assess [the] risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea. This device uses software algorithms to analyze input sensor signals and provide a risk assessment for sleep apnea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (e.g., polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnea monitor.

The definition means that Apple's sleep apnea is intended more as a preliminary step toward detecting the condition. If the tests indicate that you suffer from this disorder, then you'll naturally want to contact a doctor, who may prescribe an overnight sleep test and other measures to confirm the diagnosis.

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Apple's sleep apnea detection is part of an overall "Breathing Disturbances" option on the Apple Watch. This new metric taps into the watch's accelerometer to "detect small movements [in] the wrist associated with" respiratory interruptions while you sleep. After analyzing the data, the watch alerts you if you have "moderate to severe sleep apnea." You'll be advised to speak with a doctor, with whom you can share the data through an exported PDF.

Beyond the FDA, other global health organizations are expected to approve Apple's sleep apnea feature. The technology will be available this month in more than 150 countries and regions, including the US, the EU, and Japan.