Sunrise said the new generation of its home sleep test, Sunrise Air, has officially received FDA clearance.
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 trying to change this with an at-home solution built around a 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 sleep report for clinician review.
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.
This announcement comes on the heels of Sunrise’s $29 million 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.
