Sunrise Receives FDA Clearance for Its New Rechargeable At-Home Sleep Test, Marking a Major Advancement in Home Sleep Testing Technology

The Award-Winning, Lightweight Sunrise Air Device Sets a New Gold Standard in Smart, Multi-Night Sleep Apnea Diagnosis

NEW YORK--(BUSINESS WIRE)--Today, Sunrise Group, a pioneer in medical device innovation and sleep care, announced that the new generation of its home sleep test, Sunrise Air, has officially received FDA clearance. This clearance marks a major step forward in Sunrise’s mission to expand access to high-quality sleep care by providing a best-in-class, convenient, and clinically robust sleep apnea diagnostic solution that can be completed entirely at home.

Obstructive sleep apnea (OSA) affects more than 900 million people worldwide, yet many cases remain underdiagnosed, in part due to limited access to sleep laboratories and long waiting times for traditional polysomnography (PSG). Sunrise is changing this with a simple at-home solution built around a single, ultra-light chin-worn sensor. The Sunrise device records mandibular jaw movements (MJM), a clinically validated biosignal for sleep assessment, then analyzes the data through proprietary AI-supported algorithms to generate a comprehensive sleep report for clinician review.

With Sunrise Air, the company builds on its proven MJM technology to deliver an even more advanced home sleep testing solution. The compact device integrates additional sensors, including thermistors for airflow, an optical module for oxygen saturation and pulse rate, and an embedded microphone for precise snoring analysis. These enhancements further strengthen respiratory event detection and the assessment of respiratory effort and sleep fragmentation, supporting precise differentiation between central and obstructive apneas, even in clinically complex patients.

Designed for comfort, Sunrise Air is ultra-lightweight, ergonomic, and fully rechargeable, enabling flexible multi-night testing without disposable components. By delivering lab-grade insights in a simple, patient-friendly format, Sunrise Air makes sleep testing more accessible and reliable than ever before, without the constraints of the sleep lab.

“Sunrise has already set a new benchmark for home sleep testing through its high level of diagnostic accuracy even across complex sleep apnea phenotypes, including central sleep apnea, supported by its unique ability to measure respiratory effort," said Laurent Martinot, CEO and Co-founder of Sunrise. "With a fully rechargeable model, we're unlocking what sleep medicine has always lacked: multi-night insight with clinical-grade accuracy, from the patient's bedside. Nobody sleeps the same way twice, yet we've been diagnosing based on a single night. That changes now. This isn't just a better diagnosis. It's world-class sleep care, accessible to everyone.”

Conventional sleep tests are often cumbersome and limited to hospital or clinic settings. Sunrise, recently awarded the iF Design Award for its lightweight device and best-in-class agreement with PSG, has also received recognition from the National Sleep Foundation and the CES Innovation Awards in recent years.

This announcement comes on the heels of Sunrise’s $29M raise, which supports the expansion of the company’s clinical services, particularly through Dreem Health, the U.S.-based virtual sleep clinic, and accelerates investment in next-generation sleep technology. Sunrise is building advanced software and hardware to improve how sleep disorders are detected, monitored, and treated, with the goal of making sleep care faster, easier, and more accessible to anyone, anywhere.

About Sunrise Group

Founded in 2015, Sunrise Group® is a pioneer in medical device innovation and sleep care. The company first developed an FDA-cleared and CE-marked medical device – a lightweight, chin-worn sensor for at-home sleep apnea diagnosis using AI-supported analysis of mandibular jaw movements – that has been validated in peer-reviewed studies and endorsed by leading sleep experts. Today, Sunrise builds on that breakthrough to develop advanced software and hardware to detect, monitor, and treat sleep disorders, and brings this expertise to Dreem Health®, the U.S.-based virtual sleep clinic available in all 50 states and covered by major insurers. Headquartered in Belgium with offices in France and the United States, the team brings together leaders in sleep research, patient care, and medical technology. To learn more about Sunrise and Dreem Health, visit us.hellosunrise.com and dreemhealth.com.