Apple has secured FDA clearance for its new sleep apnea detection feature on the Apple Watch, marking a significant advancement in wearable health technology. The feature, available on Apple Watch Series 9, Series 10, and Ultra 2 via watchOS 11, is designed to identify potential signs of moderate to severe sleep apnea in users aged 18 and older who have not been previously diagnosed with the condition.
The FDA granted approval on September 13, 2024, classifying the Apple Watch feature as "Substantially Equivalent" to an "Over-The-Counter Device To Assess Risk Of Sleep Apnea." This means the technology functions similarly to existing devices designed for sleep apnea detection, offering users a convenient and accessible method for initial screening.
According to Apple's announcement, the sleep apnea detection is not intended to provide a definitive diagnosis. Instead, it serves as an alert system, prompting users who exhibit signs of the condition to consult with a healthcare professional for further evaluation and treatment. The submission to the FDA was made on April 4, 2024.
It's important to note that while watchOS 11 is compatible with Apple Watch Series 6 and later, the sleep apnea detection feature is exclusively available on the newer models (Series 9, Series 10, and Ultra 2). This limitation is due to the advanced sensor technology required for accurate sleep apnea detection.
This FDA clearance follows Apple's recent approval for its AirPods Pro 2 hearing aid feature, which allows users to enhance ambient sounds, similar to traditional hearing aids. These developments highlight Apple's increasing focus on integrating health and wellness functionalities into its consumer electronics, potentially transforming how individuals monitor and manage their health.
