Eight Sleep, the startup behind the $2,999 mattress cover that puts both Elon Musk and Mark Zuckerberg to sleep, wants to stop being known for the celebrities who use it. Instead, the company is pursuing FDA clearance to detect and treat sleep apnea, a pivot it hopes will turn a bougie tech gadget into a business that insurers, not just billionaires, will pay for.
Matteo Franceschetti, Eight Sleep’s cofounder and chief executive, told Fortune the company’s filing with the FDA is progressing “fairly smoothly.” The company began pursuing clearance with the FDA for its sleep apnea detection and mitigation technologies in 2025 and is conducting clinical studies in support of its submissions.
Currently, the company has only published one independent study on the Pod’s benefits, alongside several study preprints that were both directionally positive but not yet independently verified. There are several studies, however, funded by Eight Sleep, on sleep apnea that have been published in scientific journals. Eight Sleep also collects and has a massive cache of user data that, when aggregated and de-identified, can be used to identify broader trends and support research, reports, and studies on sleep and health.
FDA clearance for sleep apnea detection would likely put Eight Sleep in more rigorous regulatory lane as Apple’s Watch and Samsung’s Galaxy Watch and Ring, both cleared by the FDA since 2024 to flag sleep apnea “risk.” The FDA has a lower bar for the detection of apnea—snoring so bad that the sleeper stops breathing—than diagnosis.
