Eight Sleep is pursuing Eight Sleep FDA clearance for sleep apnea detection and treatment, a move that could see its $2,999 mattress cover reimbursed by insurers rather than bought out of pocket by billionaires.
Matteo Franceschetti, the company’s cofounder and chief executive, told Fortune the FDA filing is progressing ‘fairly smoothly.’ The company began seeking clearance in 2025 and is running clinical studies in support of its submissions.
Eight Sleep FDA clearance: what the company is seeking
The target is more clinically demanding than what Apple Watch or Samsung’s Galaxy Watch and Ring have already achieved. Both devices received FDA clearance since 2024 to flag sleep apnea ‘risk.’ Eight Sleep is pursuing a prescription-based diagnostic aid that would quantify apnea events per hour, a higher clinical bar.
One independent study on the Pod’s benefits has been published. Several study preprints described as directionally positive have not yet been independently verified. Eight Sleep has also funded separate sleep apnea studies that have appeared in scientific journals.
Abu Dhabi trial tests Pod as CPAP alternative
In August 2026, Eight Sleep launched a 12-week clinical trial with the Department of Health – Abu Dhabi to test whether the Pod can automatically reposition sleep apnea patients. According to the Department of Health, the trial will capture continuous sleep and physiological signals including heart rate, breathing rate, movement, apnoea events, and positional data over the 12 weeks.
The goal is to establish whether the Pod can serve as an alternative to a CPAP machine, a standard treatment that many patients find difficult to use consistently.
Eight Sleep is not alone in using Abu Dhabi as a route to medical credibility. Oura signed a joint research programme with the Department of Health on women’s health and cardiometabolic risk, while Whoop secured a $75 million investment and research partnership with Mubadala to validate its biomarker work in its first market outside the US.
The business case behind the medical pivot
Franceschetti’s aim is to get insurers to treat the Pod as a medical device. The company is working on bringing the price down, though it has not said how it gets there without a different cost structure. The Pod currently qualifies for HSA and FSA reimbursement through the fintech Truemed.
In March 2026, Eight Sleep raised $50 million from Tether, the company behind the world’s largest stablecoin, at a $1.5 billion valuation. The company has raised more than $310 million in total. Franceschetti told Fortune the company was profitable in 2025 and that cumulative Pod sales exceed $500 million. Third-party estimates put 2025 revenue at roughly $264 million, flat with 2024, though Franceschetti disputes that figure, saying revenue has grown ‘close to 30x’ since the Pod launched in 2019.
Eight Sleep now sells in 35 countries, including a 2026 launch in China, and employs roughly 100 people.
The market Eight Sleep is targeting
The CDC puts the share of American adults sleeping fewer than seven hours a night at roughly 30.5%. The American Academy of Sleep Medicine estimates undiagnosed sleep apnea costs the US nearly $150 billion a year, the exact condition the Eight Sleep FDA clearance filing targets.
The cautionary tale from the wider sleep sector is fresh. Sleep Number, the unit-share leader in smart beds, filed for Chapter 11 in June 2026 with $672 million in debt after net sales fell 16%. Sleep Country Canada bought its assets for $701 million. Eight Sleep, direct-to-consumer with a lean headcount, says it has avoided that trap by design.
Franceschetti told Fortune his ambition is for Eight Sleep to become ‘the biggest health technology company in the world.’ The next clinical milestone will be whether the FDA agrees the Pod treats a condition rather than merely tracks one.
