The U.S. Food and Drug Administration (FDA) has granted approval for the sleep apnea detection feature on the Apple Watch, paving the way for its release to consumers. This approval arrives alongside the launch of the Apple Watch Series 10 and will also be available on Apple Watch Series 9 and Apple Watch Ultra 2.
The FDA's decision, documented in a 510(k) Premarket Notification, clears an "Over-the-counter device to assess risk of sleep apnea." While the listing does not explicitly name the Apple Watch, it identifies Apple as the applicant for the "Sleep Apnea Notification Feature (SANF)." Apple applied for authorization on April 4, 2024, and received the FDA's decision on September 13.
This approval allows Apple to activate the software feature on compatible Apple Watch models via a software update scheduled for release in September across more than 150 countries. The sleep apnea detection feature addresses a significant unmet need, as it is estimated that over a billion people worldwide are affected by sleep apnea, a condition characterized by shallow breathing or pauses in breathing during sleep.
How the Technology Works
The Apple Watch utilizes its accelerometer to detect breathing disturbances by monitoring subtle movements at the wrist that correlate with respiratory patterns. The device analyzes this data over a 30-day period. If consistent signs of moderate to severe sleep apnea are detected, the user receives a notification.
There are two main types of sleep apnea: obstructive sleep apnea (OSA), caused by airway blockage, and central sleep apnea (CSA), resulting from the brain's failure to regulate breathing. Traditional diagnosis involves overnight sleep studies in a clinic, an expensive and often inaccessible process. The Apple Watch offers a convenient, preliminary screening tool.
Broader Health Initiatives
This FDA approval follows closely on the heels of another clearance for Apple, with the AirPods Pro 2 gaining approval for clinical-grade hearing aid features via a software update on September 12. These developments underscore Apple's growing role in personal health monitoring and its potential to improve access to preliminary health assessments.
