Sunrise wins FDA clearance for next-generation at-home sleep apnea test

Sunrise Group announced that its next-generation home sleep testing device, Sunrise Air, has received clearance from the U.S. Food and Drug Administration, expanding the company’s push into at-home diagnosis of obstructive sleep apnea.

The company said the newly cleared device builds on its existing mandibular jaw movement technology, which uses a lightweight chin-worn sensor to monitor jaw movements during sleep. Sunrise Air adds thermistors to measure airflow, an optical module to monitor oxygen saturation and pulse rate, and an embedded microphone designed to analyze snoring.

The company said the added sensors improve the device’s ability to detect respiratory events and distinguish between obstructive and central sleep apnea, including in patients with more complex sleep conditions.

Obstructive sleep apnea affects hundreds of millions of people worldwide and is often underdiagnosed because traditional sleep studies typically require overnight monitoring in specialized laboratories. Home sleep testing has become an increasingly important part of sleep medicine as healthcare systems seek more accessible and lower-cost diagnostic options.

Sunrise said its device is designed to provide a simpler alternative to conventional polysomnography, or PSG, which often involves multiple wired sensors and in-clinic monitoring. The company said Sunrise Air is lightweight, rechargeable and intended for multi-night use without disposable components.

“Sunrise has already set a new benchmark for home sleep testing through its high level of diagnostic accuracy even across complex sleep apnea phenotypes,” Laurent Martinot, co-founder and CEO of Sunrise, said in a statement. “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.”

The company said its proprietary artificial intelligence-supported algorithms analyze collected sleep data and generate reports for clinician review.

Sunrise recently raised $29 million to support expansion of its clinical services and further development of sleep technology products. The company said part of the funding will support growth of Dreem Health, its U.S.-based virtual sleep clinic.

The company also noted that its technology has received recognition in recent years from organizations including the National Sleep Foundation, the CES Innovation Awards and the iF Design Award program.