FDA Clears First Smart Ring to Diagnose Sleep Apnea at Home
Most people with sleep apnea go undiagnosed — Happy Ring aims to change that with an at-home test, virtual care and insurance-covered treatment options.
By
Lana Pine
| Published on June 24, 2025
3 min read
Credit: Happy Health
The U.S. Food and Drug Administration (FDA) has officially cleared the Happy Ring as a Class II medical device to help diagnose sleep apnea, insomnia and other sleep-related conditions — all from the comfort of home.
“Sleep is the foundation of health and the ‘canary in the coal mine’ of disease,” said Dustin Freckleton, M.D., founder and CEO of the Austin-based digital-health company Happy Health. “When we measure sleep accurately in people’s 20s, 30s and 40s, we expose the patterns that drive heart disease, hypertension, metabolic and behavioral disorders decades later.”
The smart ring pairs with a virtual sleep platform called Happy Sleep, letting users take a sleep test overnight, review results with a board-certified sleep doctor and begin treatment — all without ever stepping into a clinic. Patients can create an individualized plan with their doctor, which may include continuous positive airway pressure (CPAP), PAP-alternative dental appliances and even glucagon-like peptide-1 (GLP-1) therapies.
This is particularly important because people with severe sleep apnea are at three times greater risk of death, according to a study conducted by the American Academy of Sleep Medicine.
The ring has been previously cleared by the FDA for tracking key health metrics, including heart rate, activity, temperature, brain activity and more.
Now, it’s the only ring that combines multinight sleep studies (with 97% accuracy compared with traditional lab-based sleep tests) and a round-the-clock health monitor ring in one device.
This new at-home approach could be a game changer, especially for the 80% of Americans with sleep apnea who go undiagnosed. Happy Ring makes it easier to catch and treat sleep issues early — before they contribute to bigger problems, including heart disease, high blood pressure or diabetes. The process is covered by many major insurers, and the device is designed to be comfortable and stylish enough to wear every day.
“Happy Ring is much more than a sleep device,” Jeff Durmer, M.D., Ph.D., neurologist and adviser to Happy Health, said in the announcement. “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.”
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