AUSTIN, Texas– The Happy Ring, a sleek smart wearable from Happy Health Inc., has received its second FDA clearance—this time as a Class II medical device for at-home diagnosis of obstructive sleep apnea, insomnia, and other sleep-related disorders. With this milestone, the Happy Ring becomes the first and only FDA-cleared smart ring capable of both multi-night sleep testing and continuous, 24/7 biometric monitoring.
Through the company’s virtual Happy Sleep platform, users can now complete the entire diagnostic process from home: ordering the test online, wearing the ring overnight, and consulting a board-certified sleep physician virtually. Based on the results, patients are guided into personalized treatment plans that may include CPAP therapy, dental appliances, or even newly approved GLP-1 medications like Zepbound. The service is covered by most major U.S. insurance providers.
“Sleep is not just a pillar of health—it’s often the earliest signal of disease,” said Dr. Dustin Freckleton, CEO and founder of Happy Health. “When we accurately measure sleep patterns early in life, we uncover indicators that precede heart disease, metabolic disorders, and mental health conditions. This is just the beginning for the Happy Ring.”
The FDA clearance arrives at a time of growing urgency in sleep medicine. Of the estimated 30 million American adults affected by sleep apnea, up to 80% remain undiagnosed—despite research showing untreated cases can nearly quadruple all-cause mortality. The Happy Ring aims to close this gap by replacing invasive, clinical sleep studies with a discreet, jewelry-like device that people can wear at home.
Crafted from diamond-hard ceramic and engineered for comfort and durability, the Happy Ring merges aesthetics with clinical-grade performance. Under its minimalist design lies a suite of advanced sensors that match the accuracy of gold-standard polysomnography (PSG) testing, with 97% concordance.
Dr. Jeff Durmer, a neurologist and advisor to Happy Health, called the technology a breakthrough in digital healthcare. “The Happy Ring delivers hospital-level diagnostics to any bedroom. It’s a powerful tool for improving care access, enhancing early detection, and reducing long-term healthcare costs,” he said.
With same-day virtual appointments, integrated insurance billing, and financing options, Happy Health is redefining the sleep diagnostic process—making it faster, more comfortable, and more accessible. The company also hinted at future capabilities, suggesting the device could soon help detect related cardiovascular and metabolic disorders before they manifest.
As Dr. Freckleton put it, “The best is yet to come.”
