Apple Watch and Samsung Galaxy Watch models can now flag signs of moderate-to-severe sleep apnea, but the features are screening tools only and do not diagnose the disorder.
Apple’s feature works on Series 9 and later, Ultra 2 and 3, and SE 3, using accelerometer data after at least 10 nights of tracked sleep within 30 days for users age 18 and older.
Samsung’s version runs on Galaxy Watch 4 and newer paired with a Galaxy phone, requiring just 2 nights of sleep data within 10 days and targeting users age 22 and older.
FDA backing remains rare in wearables: Samsung received De Novo authorization in 2024, Apple later won 510(k) clearance, while rivals such as Garmin and Oura offer breathing metrics without comparable clearance.
When your smartwatch flags a potential illness, who profits from routing you toward specific medical services?
As our watches become medical devices, are regulators prepared for the ethical challenges of AI-driven healthcare?
Can wearable health alerts do more harm than good by creating a wave of unnecessary medical anxiety and tests?
FDA-Cleared Smartwatches for Sleep Apnea Screening: How Apple and Samsung Are Transforming Consumer Health in 2024-2025
Overview
In 2024 and 2025, the FDA cleared sleep apnea screening features for Samsung and Apple smartwatches, marking a major shift in consumer health technology. These approvals transformed everyday wearables from simple fitness trackers into advanced tools for medical-grade health monitoring. By using machine learning and artificial intelligence, these devices now help address important public health challenges directly from the wrist. This advancement meets a critical need, as sleep quality greatly affects overall well-being. The integration of such technology empowers users to monitor their health more closely and encourages earlier detection of sleep disorders like sleep apnea.