Apple Watches Achieve FDA Approval As Sleep Apnea Detectors

Images via Apple and 75745956 © Dmytro Konstantynov | Dreamstime.com

Apple has just earned another health win—this time, with the US Food and Drug Administration (FDA)’s approval of a new feature on the Apple Watch that can help detect sleep apnea. The software boost comes hot on the heels of the AirPods 2 being authenticated as “clinical-grade” hearing aids.

The Apple Watch Series 9, Series 10, and Watch Ultra 2 can now track “breathing disturbances” during sleep, potentially indicating sleep apnea—a condition, where breathing repeatedly stops and starts throughout the night, that often goes unnoticed by those affected.

These disruptions—subtle movements at the wrist linked to interruptions in normal breathing—are logged into a new metric called Breathing Disturbances, viewable in the Health app. Users can see patterns over a one-month, six-month, or year-long period, with the data flagged as elevated or not elevated.

Image via Apple

This update is significant because sleep apnea is a common but underdiagnosed issue affecting millions worldwide. Left unchecked, it can lead to serious health problems like heart disease or high blood pressure. Now, the Apple Watch gives users an over-the-counter way to assess their risk without needing clinical equipment. The feature notifies wearers if it detects consistent breathing disturbances and encourages them to consult a healthcare professional.

The timing of the FDA approval aligns with the release of watchOS 11, which activates this new capability.

The feature’s algorithm analyzes data over 30-day periods, notifying users if signs of sleep apnea are detected. These notifications include the time frame of potential occurrences, educational materials on treatment importance, and a PDF with three months of breathing disturbance data for users to share with healthcare providers.

Apple’s sleep apnea detection feature was developed using advanced machine learning and data from thousands of clinical-grade sleep apnea tests. It underwent validation in what the tech giant claims is the largest study ever conducted for FDA clearance of a sleep apnea device. 

Following FDA 510(k) clearance and additional global health authority approvals, the feature is now available in over 150 countries and regions such as the US, the EU, and Japan.

[via CNBC, PCMag, CBS News, iDrop News, images via various sources]