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The US Food and Drug Administration (FDA) has approved Apple’s new sleep apnoea detection feature, set to launch on the Apple Watch Series 10, Series 9, and Watch Ultra 2.

The FDA granted approval for this highly anticipated feature on Monday, ahead of the Apple Watch Series 10 release, scheduled for September 20. First announced during the iPhone 16 launch event last week, this sleep apnoea detection tool is set to debut as part of the watchOS 11 release.

“This device uses software algorithms to analyse input sensor signals and provide a risk assessment for sleep apnoea. It is not intended to provide a standalone diagnosis, replace traditional methods of diagnosis (polysomnography), assist clinicians in diagnosing sleep disorders, or be used as an apnoea monitor,” the FDA stated.

Apple’s new feature, while not a diagnostic tool, serves as a powerful prompt for users to seek formal medical evaluation. By leveraging advanced machine learning algorithms, the tool analyses sleep patterns, using data from clinical-grade sleep apnoea tests.

The Apple Watch Series 10 will be the first model to feature this innovative tool, but it will also be supported on the Series 9 and Watch Ultra 2. The sleep apnoea detection feature works by tracking breathing disturbances during sleep, a hallmark of the serious sleep disorder in which breathing repeatedly stops and starts.

The new breathing disturbances metric uses the watch’s accelerometer to monitor subtle wrist movements linked to respiratory disruptions. If the watch consistently detects signs of moderate to severe sleep apnoea, users will receive a notification, encouraging them to seek further evaluation from healthcare professionals.

Sleep apnoea is a common but serious condition that affects millions globally, often going undiagnosed for long periods. Early detection can play a vital role in preventing complications like heart disease, stroke, and high blood pressure. With this new feature, Apple Watch users will have a tool that can help them recognise potential warning signs early.

Apple plans to roll out the sleep apnoea detection feature in 150 countries following FDA approval. The feature will join other health-monitoring tools on the Apple Watch, such as Afib alerts, cardio fitness tracking, and the ECG app, enhancing the watch’s reputation as a versatile health companion.

As wearable technology continues to evolve, Apple’s foray into sleep disorder detection signals a growing focus on health monitoring, empowering users to stay more informed about their well-being.

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