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Apple Watch Receives FDA Clearance for Sleep Apnea Detection

• The FDA has approved sleep apnea detection for Apple Watch Series 9, Series 10, and Watch Ultra 2, accessible via the upcoming watchOS 11 update. • The feature requires 10 nights of sleep tracking over 30 days, utilizing the accelerometer to identify potential sleep disturbances. • Apple emphasizes that the feature is not a diagnostic tool but an over-the-counter risk assessment, prompting users to seek professional diagnosis. • This approval follows similar clearances for sleep apnea detection in devices from Withings and Samsung's Galaxy Watch line.

The Apple Watch Series 9, Series 10, and Watch Ultra 2 have received FDA clearance for a new feature that detects potential signs of sleep apnea. The approval, granted on Monday, precedes the release of the Series 10 and will be available through the watchOS 11 update. This feature aims to provide users with an initial risk assessment, encouraging them to seek further medical evaluation if necessary.

How the Feature Works

To utilize the sleep apnea detection, users will need to enable sleep tracking on their Apple Watch. The system requires data from at least 10 nights of sleep, collected over a 30-day period, to establish a baseline and identify potential irregularities. The Apple Watch's built-in accelerometer monitors movements during sleep, providing insights into disturbances that may indicate sleep apnea.

Intended Use and Limitations

Classified by the FDA as an over-the-counter risk assessment tool, the sleep apnea detection feature is not designed to replace professional medical diagnoses. Apple explicitly states that the feature is intended to prompt users to consult healthcare providers for formal diagnosis and treatment plans. Sleep apnea, characterized by shallow or interrupted breathing during sleep, can lead to various health issues, including insomnia, headaches, and daytime sleepiness.

Market Context

Apple is not the first consumer electronics company to incorporate sleep apnea detection into its devices. Withings has offered similar capabilities for some time, and Samsung's Galaxy Watch line received FDA clearance for its sleep apnea detection feature earlier this year. These advancements reflect a growing trend of integrating health monitoring technologies into wearable devices.

Broader Implications

The introduction of sleep apnea detection on the Apple Watch arrives amidst other changes to the device's health features. Notably, blood oxygen detection has been temporarily disabled on Apple Watches sold in the U.S. due to an ongoing patent dispute. Despite this setback, the addition of sleep apnea detection underscores Apple's continued focus on expanding the health-related functionalities of its wearable technology.
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Reference News

[1]
Apple Watch sleep apnea detection gets FDA approval - TechCrunch
techcrunch.com · Sep 16, 2024

FDA approves sleep apnea detection on Apple Watch Series 9, 10, and Ultra 2, requiring 10 nights of data over 30 days. T...

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