FDA Clears Samsung Galaxy Watch for Sleep Apnea Detection

The FDA's De Novo has approved a sleep apnea detection feature on the Samsung Galaxy Watch, paving the way for an upcoming software update to the Samsung Health Monitor app. Scheduled for release in the third quarter of this year, the update will enable users in the US to access the sleep apnea tracking functionality. Approval from South Korea's Ministry of Food and Drug Safety was obtained last fall, with the feature set to roll out there initially.

Despite medical caution regarding the reliability of smartwatches for health monitoring, leading wearable manufacturers like Apple, Fitbit, and Withings are venturing into this domain. Bloomberg reported Apple's ongoing efforts to incorporate advanced health monitoring features, including sleep apnea and hypertension detection, into future Apple Watch models.

To utilize the sleep apnea detection feature on the Samsung Galaxy Watch, users must wear the device during sleep and monitor their sleep patterns twice within ten days, with each session lasting at least four hours. The Galaxy Watch tracks blood oxygen levels throughout the night, detecting potential drops indicative of sleep apnea or other sleep disorders.

Breathing interruptions during sleep serve as critical symptoms of central and obstructive sleep apnea, as outlined by the Mayo Clinic. Central sleep apnea occurs when the brain fails to send signals to breathing muscles, while obstructive sleep apnea results from throat muscles obstructing airflow to the lungs.

While wearables advance in health monitoring capabilities, including sleep apnea detection, users should remain mindful of the limitations and consult medical professionals for accurate diagnosis and treatment recommendations.