First FDA-cleared smart ring for multi-night sleep testing and 24/7 biometrics — to catch disease early—years before standard care.

, /PRNewswire/ -- 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."

Why It Matters

What Makes Happy Ring Different

"Happy Ring is much more than a sleep device," said Jeff Durmer, MD, PhD, neurologist and advisor to Happy Health. "It brings hospital-level insights to any bedroom, opening a new frontier for how we deliver care. By expanding access, elevating diagnostic quality, and lowering total cost, this technology reshapes not only sleep medicine but the broader practice of medicine for patients everywhere."

About Happy Health

Happy Health is an Austin-based digital-health company reimagining preventive care. Its Happy Sleep™ program pairs FDA-cleared wearables with board-certified physicians and insurer-integrated workflows, bringing high-quality sleep medicine—and the early detection it enables—straight to the home. Learn more at www.happysleep.com.

Happy Sleep Media Contact:

Alana Massar, Email: [email protected]

SOURCE Happy Health, Inc.