Samsung will bring an FDA-cleared Sleep Apnea Feature to the Galaxy Ring this fall, making it the first over-the-counter smart ring cleared to assess a user’s risk of the condition.
According to FDA records, Samsung submitted the Sleep Apnea Feature v2.0 for 510(k) clearance in March, and the agency determined it was substantially equivalent to a legally marketed device on July 20. The feature uses an AI algorithm to count breathing disruptions per hour and sorts results into three risk levels.
Users wear the ring for two nights within a 10-day period. The tool is meant to flag signs of moderate to severe obstructive sleep apnea in adults who have not yet been diagnosed, and Samsung stresses it does not provide a diagnosis or replace evaluation by a clinician.
Samsung digital health lead Sharanya Desai announced the feature at the Galaxy Unpacked event, saying the ring would become the first and only FDA-cleared over-the-counter ring device for sleep apnea risk detection.
The company’s Galaxy Watch sleep apnea feature received De Novo authorization in 2024, and Apple won FDA clearance for sleep apnea detection on the Apple Watch in September 2024. The ring clearance extends the category to a new form factor at the device’s $399 price point.
