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.
The FDA clearance reaffirms the growing importance of consumer-friendly diagnostic tools in reshaping chronic care. Designed with comfort, aesthetics, and clinical rigor in mind, the Happy Ring stands out as a durable, jewelry-like device with hospital-grade intelligence. By unifying diagnosis, treatment, and monitoring in a single experience—covered by most insurers—Happy Health is not only democratizing access to sleep care but pioneering a new model for remote, preventative healthcare.
MedTech Spectrum's Summary
Breakthrough in Home-Based Diagnostics: Happy Ring becomes the first FDA-cleared smart ring for both sleep apnea diagnosis and 24/7 physiologic monitoring, offering a clinically validated, non-invasive alternative to traditional sleep studies.
Improved Access and Patient Engagement: With a fully virtual pathway from testing to personalized treatment—covered by most insurers—Happy Ring makes high-quality sleep care more accessible, convenient, and continuous.
Foundation for Broader Preventive Health: By detecting sleep-related disorders early, the platform helps uncover risks tied to chronic conditions like heart disease and diabetes, positioning Happy Ring as a scalable tool for proactive health management.
