Happy Health has received its second FDA clearance for the Happy Ring, now authorized as a Class II medical device for at-home diagnosis of sleep apnea, insomnia, and related sleep disorders. Building on its prior clearance for continuous physiologic monitoring, the Happy Ring becomes the first FDA-cleared smart ring to combine multi-night sleep testing with 24/7 biometrics. With 97% accuracy compared to gold-standard polysomnography (PSG), the ring enables a fully virtual care pathway through Happy Sleep, where users can order a sleep test, receive a remote consultation, and begin treatment without leaving home.

This innovation addresses a critical healthcare gap—up to 80% of the 30 million U.S. adults with sleep apnea remain undiagnosed. Untreated sleep disorders can lead to serious cardiovascular, metabolic, and mental health issues. By replacing in-lab sleep studies with a discreet, sensor-rich wearable and providing seamless access to board-certified sleep physicians, CPAP and dental therapies, and even GLP-1 medications like Zepbound, Happy Ring empowers users to proactively manage sleep health and prevent downstream disease.