
Happy Health, an Austin-based digital-health company, has announced that its Happy Ring has received a second clearance from the US Food and Drug Administration (FDA), now allowing its use for at-home sleep testing.
The device is approved as a Class II medical device to aid in diagnosing obstructive sleep apnoea, insomnia, and other sleep-related disorders within a home setting. This development follows the Happy Ring’s initial FDA clearance, which endorsed its use for comprehensive and continuous monitoring of brain and body biometrics.
The Happy Ring is said to be the only FDA-cleared smart ring that offers multi-night sleep testing, boasting 97% accuracy compared to the gold standard polysomnography (PSG), along with 24/7 physiological monitoring.
Happy Health founder and CEO Dustin Freckleton said: “Sleep is the foundation of health and the ‘canary in the coal mine’ of disease.
“When we measure sleep accurately in people’s twenties, thirties, and forties, we expose the patterns that drive heart disease, hypertension, metabolic, and behavioural 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.”
Happy Health’s Happy Sleep platform allows individuals to order a sleep test online, wear the Happy Ring overnight, and subsequently discuss results with a board-certified sleep physician from their homes.
During these consultations, patients can develop tailored treatment plans with their physicians.
Options range from gold-standard continuous positive airway pressure (CPAP) therapy to alternatives like dental appliances and the latest FDA-approved GLP-1 therapies, such as Zepbound. These services are said to be covered by most major US insurance providers.
According to the company, the Happy Ring features an elegant design crafted from lightweight, diamond-hard ceramic, polished like fine jewellery. Despite its minimalist appearance, it houses clinical-grade sensors that enable multi-night sleep studies and continuous health monitoring in one device.