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Apple Watch Receives Regulatory Clearance for Sleep Apnea Detection

10 months ago3 min read
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Key Insights

  • Apple Watch's new sleep apnea detection feature has been approved by both the FDA in the United States and Health Canada, paving the way for its rollout.

  • The feature, available on Apple Watch Series 9, Series 10, and Ultra 2, utilizes the accelerometer to detect breathing disturbances during sleep.

  • Apple plans to launch the sleep apnea detection feature in over 150 countries, aiming to address the widespread undiagnosed cases of this condition.

Apple's sleep apnea detection feature for the Apple Watch has received clearance from both the U.S. Food and Drug Administration (FDA) and Health Canada, enabling its deployment to eligible Apple Watch models. This feature is designed to identify breathing disturbances during sleep, offering users a tool to monitor and manage potential sleep apnea.
The sleep apnea detection capability is supported on the Apple Watch Series 9, Series 10, and Ultra 2. The technology employs the watch's accelerometer to detect subtle movements associated with interruptions in normal respiratory patterns during sleep. Apple detailed that the watch analyzes breathing disturbance data every 30 days and alerts users if it detects consistent signs of moderate to severe sleep apnea, advising them to consult with a healthcare provider for further evaluation and treatment.

Understanding Sleep Apnea

Sleep apnea is a prevalent condition characterized by repeated interruptions in breathing during sleep, leading to reduced oxygen supply to the body. It is estimated to affect over one billion people worldwide, with a significant number of cases remaining undiagnosed. Untreated sleep apnea can lead to serious health consequences, including hypertension, type 2 diabetes, and cardiovascular issues. In India, a 2023 study from AIIMS New Delhi indicated that approximately 11% of adult Indians, around 104 million people, suffer from obstructive sleep apnea.
Many individuals with sleep apnea are unaware of their condition because it occurs during sleep. Apple's new feature aims to address this by providing users with a means to monitor their sleep and detect potential breathing issues early on.

How the Apple Watch Detects Sleep Apnea

The Apple Watch's accelerometer detects small wrist movements during sleep that are indicative of irregular breathing patterns. These movements are analyzed using a proprietary algorithm developed with machine learning and data from clinical-grade sleep apnea tests. If the algorithm detects significant breathing disturbances, users receive notifications prompting them to consult a healthcare provider. The Health app generates a PDF report of the data, which can be shared with healthcare professionals.
The introduction of this feature aligns with Apple’s broader strategy to enhance user health through wearable technology. Users can monitor their "breathing disturbances" metric in the Health app, classified as either "elevated" or "not elevated." The feature allows users to track patterns over time, including detailed assessments over 30 days, six months, or one year.
Apple is not the first to introduce sleep apnea detection in a smartwatch; Samsung’s Galaxy Watch received FDA authorization for a similar feature earlier in the year.
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