Eight Sleep, the startup behind a temperature controlled mattress cover that has become a fixture in Silicon Valley bedrooms, is working to transform itself from a consumer wellness brand into a regulated healthcare company.
The company's Pod system, which costs around 3,000 dollars, has drawn a following among some of tech's most recognizable names. Meta chief executive Mark Zuckerberg has said he has dialed in his sleep using Eight Sleep alongside the wearable ring maker Oura, while Tesla and SpaceX chief Elon Musk has offered a brief endorsement of the product as well. That kind of high profile usage has helped fuel demand for a device originally marketed as a way to optimize temperature and sleep quality.
From Gadget to Medical Device
Eight Sleep is now pursuing a Class II clearance from the Food and Drug Administration for technology designed to detect and help mitigate obstructive sleep apnea, a common condition in which breathing repeatedly stops and starts during sleep. Cofounder and chief executive Matteo Franceschetti has said the company began pursuing that clearance in 2025 and has been running clinical studies to support its filing, which he described as progressing smoothly.
A Class II designation sits below the strictest tier of FDA oversight but still requires clinical evidence and puts Eight Sleep in the same regulatory category as devices such as blood pressure cuffs and pulse oximeters. Winning that clearance would let the company market its technology as a legitimate diagnostic and treatment tool rather than simply a comfort upgrade, opening the door to insurance reimbursement and partnerships with health providers.
Backing From Investors Betting on Longevity
The healthcare push comes after Eight Sleep closed a 50 million dollar funding round in March that valued the company at 1.5 billion dollars, led by Tether Investments. The round reflects a broader wave of investor interest in longevity focused technology, an area that has attracted billions of dollars from wealthy backers eager to fund tools that promise better health and a longer lifespan.
Eight Sleep says its technology has been associated with meaningfully quieter sleep and fewer nighttime awakenings for users, claims the company hopes will carry more weight once backed by a formal medical clearance. If the FDA filing succeeds, Eight Sleep would join a small but growing group of consumer technology companies attempting to cross over into regulated medicine, a transition that could reshape how the company is valued and who it ultimately sells to.
