Samsung Electronics America has introduced an upgraded Sleep Apnea detection feature across its Galaxy Ring and compatible Galaxy Watch devices in the United States. The rollout follows 510(k) clearance from the US Food and Drug Administration (FDA) in July 2026 and regulatory approval from South Korea’s Ministry of Food and Drug Safety (MFDS).
The development marks the first FDA-cleared over-the-counter sleep apnea risk-detection software designed for a smart ring. Available through the Samsung Health Monitor application, the upgraded functionality provides users with quantified estimates of breathing disruptions during sleep, extending beyond the risk notifications offered by earlier versions.
Samsung initially received FDA De Novo authorization in February 2024 for wearable-based detection of moderate-to-severe obstructive sleep apnea (OSA) through its Galaxy Watch series. The original feature primarily identified physiological patterns associated with potential sleep apnea risk, providing users with notifications rather than detailed measurements.
The updated technology introduces several capabilities intended to support sleep health monitoring and clinical discussions.
Its algorithm analyzes peripheral blood oxygen saturation (SpO2), photoplethysmography (PPG) pulse waveforms, and accelerometer movement data to estimate the number of breathing disruptions occurring per hour of sleep.
The screening process requires two nights of valid sleep tracking within a rolling 10-day period, reducing the monitoring requirements for users. Adults aged 18 and older can access their results through Samsung Health Monitor and share recorded trends with healthcare professionals to inform discussions about further diagnostic testing.
The feature is currently available on Galaxy Ring and Galaxy Watch9 devices running Wear OS 7.0 or later. Samsung also plans to extend compatibility to Galaxy Watch7 and Galaxy Watch8 models through subsequent firmware updates.
Jongmin Choi, Head of Health R&D Group, Mobile eXperience Business at Samsung Electronics, stated: “Samsung has long worked to make sleep health a simple and seamless part of everyday life. This approval from Korea’s MFDS, along with our introduction of the world’s first FDA cleared over-the-counter smart ring, reflects our commitment to accessible innovation. We are giving people the tools to help spot possible early signs of sleep apnea and take charge of their wellbeing.”
The technology is intended to support preliminary risk identification rather than replace clinical diagnosis, with confirmatory sleep studies remaining necessary for patients requiring further evaluation.
Click here for the original news story.
