Sunrise’s Next-Gen Home Sleep Test Wins FDA Nod

Sunrise Group revealed that the new generation of its home sleep test, Sunrise Air, has received U.S. Food and Drug Administration (FDA) clearance.

Sunrise’s simple at-home solution is built around a single, ultra-light, chin-worn sensor. The device records mandibular jaw movements (MJM), a biosignal for sleep assessment. It then analyzes the data through proprietary artificial intelligence (AI)-supported algorithms to create a comprehensive sleep report that clinicians can review.

The new, compact device integrates more sensors, including thermistors for airflow, an optical module for oxygen saturation and pulse rate, and an embedded microphone for precise snoring analysis. The company said the enhancements bolster respiratory event detection and evaluation of respiratory effort and sleep fragmentation to support precise differentiation between central and obstructive sleep apneas.

Sunrise Air is fully rechargeable, which enables flexible multi-night testing without disposable components. It provides lab-grade insights in a simple, patient-friendly format to make sleep testing more accessible and reliable, without the constraints of the sleep lab.

This announcement follows Sunrise’s $29 million funding raise, supporting the expansion of clinical services, particularly through Dreem Health, the U.S.-based virtual sleep clinic, and accelerating investment in next-generation sleep technology.

“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, co-founder and CEO 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.”