Eight Sleep shifts from luxury mattress to FDA-cleared sleep-apnea medical device

Eight Sleep, known for its premium smart-mattress Pod used by figures such as Elon Musk and Mark Zuckerberg, is pivoting toward a medical-device model by applying for FDA clearance to detect and treat sleep apnea. Co-founder and chief executive Matteo Franceschetti reports that the submission, begun in 2025, is moving “fairly smoothly” and is backed by clinical studies, including a trial with Abu Dhabi’s Department of Health testing automatic repositioning as an alternative to CPAP.

The firm hopes insurers will cover the Pod, which already qualifies for HSA/FSA reimbursement through Truemed, and is working to lower its price. While only one independent study on the Pod’s benefits exists, several company-funded apnea studies have appeared in journals, and the company holds a large de-identified user data set for research. Recent financing includes a $50 million round from Tether at a $1.5 billion valuation, and partnerships with Formula 1’s Aston Martin Aramco. Franceschetti envisions Eight Sleep becoming the world’s largest health-technology company, expanding beyond billionaire clientele to patients with conditions like temperature-regulation disorders.