Happy Health today announced that the U.S. Food and Drug Administration has cleared the Happy Ring as a class II medical device to facilitate the diagnosis of obstructive sleep apnea, insomnia, and other sleep related conditions in the home. This new clearance builds on the Happy Ring’s earlier FDA clearance for comprehensive, continuous brain and body biometrics, making Happy Ring the only FDA-cleared smart ring that combines multi-night sleep testing (97% accurate to gold standard PSG) with 24/7 physiologic monitoring.
Through the company’s Happy Sleep platform, individuals order a sleep test online, wear the ring overnight, and review the results with a board-certified sleep physician – all in the comfort of their own home. During the visit, patients create an individualized treatment plan with their provider—ranging from gold-standard CPAP to PAP-alternative dental appliances and the newest FDA-approved GLP-1 therapies such as Zepbound—so patients move from testing to the right solution without ever leaving home. These services are covered by most major U.S. insurers.
“Sleep is the foundation of health and the ‘canary in the coal mine’ of disease,” said Dustin Freckleton, MD, founder and CEO of Happy Health. “When we measure sleep accurately in people’s twenties, thirties, and forties, we expose the patterns that drive heart disease, hypertension, metabolic, and behavioral disorders decades later. This clearance is just the beginning. Our sensor-rich ring will be diagnosing those comorbid conditions next, in the very near future. The best is yet to come.”
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Why It Matters
- Large unmet need — Up to 80% of the 30 million U.S. adults with sleep apnea never receive a diagnosis, and untreated cases raise all-cause mortality nearly 4x
- Early warning system — Insomnia and disrupted sleep often appear alongside—or years before—cardiovascular, metabolic, and mental-health conditions.
- Consumer-first care — A comfortable ring replaces clinical visits and hospital stays, encouraging people to test sooner and stay engaged longer.
