The FDA clearance came ahead of the availability of the Apple Watch Series 10 starting September 20.
The long-awaited feature was announced at the iPhone 16 launch last week and will arrive as part of the watchOS 11 launch.
“This device uses software algorithms to analyze input signals from the sensors and provide a sleep apnea risk assessment. “It is not intended to provide a stand-alone diagnosis, replace traditional diagnostic methods (polysomnography), help doctors diagnose sleep disorders, or be used as an apnea monitor,” according to a US FDA statement.
The operating principle is based on the analysis of physiological signals to evaluate sleep apnea.
According to Apple, the feature is not a diagnostic tool, but will prompt users to seek a formal diagnosis.
The sleep apnea detection feature is new to the Apple Watch, starting with the Series 10 model. It will be compatible with Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2.
According to the tech giant, the sleep notification algorithm was developed using advanced machine learning and an extensive data set of clinical-grade sleep apnea tests.
The innovative respiratory disturbance metric will track users' sleep, analyze sleep patterns and notify them in case of apnea.
Apple said the breathing disturbance metric uses the accelerometer to detect small movements in the wrist associated with disruptions to normal breathing patterns during sleep and then notifies users if they show ongoing signs of moderate to severe sleep apnea.
The sleep apnea feature will be rolled out to 150 countries after approval by the US FDA. Other standard health features, such as Afib alerts, cardio exercise, and ECG app, from previous models Apple Watch are also present in the latest model.
The long-awaited feature was announced at the iPhone 16 launch last week and will arrive as part of the watchOS 11 launch.
“This device uses software algorithms to analyze input signals from the sensors and provide a sleep apnea risk assessment. “It is not intended to provide a stand-alone diagnosis, replace traditional diagnostic methods (polysomnography), help doctors diagnose sleep disorders, or be used as an apnea monitor,” according to a US FDA statement.
The operating principle is based on the analysis of physiological signals to evaluate sleep apnea.
According to Apple, the feature is not a diagnostic tool, but will prompt users to seek a formal diagnosis.
The sleep apnea detection feature is new to the Apple Watch, starting with the Series 10 model. It will be compatible with Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2.
According to the tech giant, the sleep notification algorithm was developed using advanced machine learning and an extensive data set of clinical-grade sleep apnea tests.
The innovative respiratory disturbance metric will track users' sleep, analyze sleep patterns and notify them in case of apnea.
Apple said the breathing disturbance metric uses the accelerometer to detect small movements in the wrist associated with disruptions to normal breathing patterns during sleep and then notifies users if they show ongoing signs of moderate to severe sleep apnea.
The sleep apnea feature will be rolled out to 150 countries after approval by the US FDA. Other standard health features, such as Afib alerts, cardio exercise, and ECG app, from previous models Apple Watch are also present in the latest model.