Apple recently demoed an intriguing new feature with the Apple Watch Series 10 that can detect early warning signs of sleep apnea. With only a few days until the official release of the new Watch series, the FDA has approved the feature for use in the United States.
Today, the Food and Drug Administration website added the “Sleep Apnea Notification Feature (SANF)” to its database of medical devices. It’s classified as an over-the-counter device for sleep apnea risk assessment. “An over-the-counter device to assess risk of sleep apnea is intended to provide a notification of the risk of sleep apnea in users who have not been previously diagnosed with sleep apnea,” the database explains. The FDA also warns that it’s not a substitute for a real diagnosis.
The Sleep Apnea Notification Feature works by counting “breathing disturbances” the wearer experiences. It tracks these sleep disturbances over a span of a month and tells you if the signs are “elevated.” Elevated levels of breathing disturbances could point to moderate or severe sleep apnea.
When breathing stops during sleep, the wrists make subtle motions, which the accelerometer inside the Apple Watch picks up. These readings are then fed to algorithms built on clinical studies and tests to determine the severity of the disturbances. Apple says their Watch successfully discovered signs of sleep apnea in the lab. “In the clinical validation study, every participant identified by the algorithm had at least mild sleep apnea,” Apple’s announcement reads.
The Watch will notify you if you potentially have sleep apnea and create an exportable chart of your past breathing disturbances that you can show your doctor. The same data is also pooled in the Health app on the iPhone.
Apple Watch Series 10 will become available from September 20. And the FDA authorization is just the first of many to come for the new Apple Watch, since Apple is planning to release it in 150 countries, and it’ll need approval from the health organizations in other countries.
