Eight Sleep, a New York-based developer of smart sleep products, has raised US$100 million in a series D round.

The funding round included investors HSG (formerly HongShan Capital/Sequoia Capital China), Valor Equity Partners, Founders Fund, and Y Combinator.

Khosla Ventures, a previous backer, did not join this round.

CEO Matteo Franceschetti said that the company plans to file two applications with the US Food and Drug Administration (FDA) this month for medical device classifications, targeting sleep apnea and menopause.

Franceschetti also said that Eight Sleep aims to launch branded retail stores in 2026 and expand further in Asia.

🔗 Source: Axios

🧠 Food for thought

1️⃣ FDA regulatory pathways for sleep technology are rapidly expanding

Eight Sleep’s plan to file FDA applications reflects a broader trend of increasing medical device certifications in the sleep technology space.

Home sleep apnea testing device certifications increased significantly after 2022, with most devices focusing on respiratory events and sleep analysis metrics like the apnea-hypopnea index 1.

The FDA has also expanded its definition of medical devices to include consumer sleep products, as seen when it authorized the SNOO Smart Sleeper as a medical device in 2023 2.

This regulatory evolution creates clearer pathways for sleep tech companies to gain medical credibility while accessing larger healthcare markets, explaining why Eight Sleep is pursuing both sleep apnea and menopause classifications simultaneously.

The company’s timing aligns with established precedent. The FDA already classified a digital therapy device for sleep disturbances as Class II in 2023, demonstrating regulatory acceptance of technology-based sleep interventions 3.

2️⃣ Sleep quality research provides compelling market validation for smart sleep products

The push for widespread wearable adoption gains scientific support from research showing sleep’s direct impact on mortality.

A 12.8-year study of 185 healthy older adults found that poor sleep quality significantly increases death risk. Sleep latencies over 30 minutes increased mortality risk by 2.14 times, while sleep efficiency below 80% increased risk by 1.93 times 4.