Sunrise Group, a medical technology company focused on sleep care innovation, has received US Food and Drug Administration (FDA) clearance for Sunrise Air, the latest generation of its home sleep testing device designed to improve access to Obstructive Sleep Apnoea (OSA) diagnosis. 

Obstructive sleep apnoea affects more than 900 million people globally, but diagnosis rates remain low due to limited access to sleep laboratories and long waiting periods for conventional polysomnography (PSG) testing. Sunrise aims to address this gap through a lightweight, chin-worn device that records mandibular jaw movements (MJM), a clinically validated biosignal used in sleep assessment. The collected data is processed using proprietary AI-supported algorithms to generate sleep reports for clinical review.

The newly approved Sunrise Air expands on the company’s established MJM technology by integrating additional diagnostic capabilities. The device includes thermistors for airflow monitoring, an optical module for oxygen saturation and pulse rate measurement, and an embedded microphone for snoring analysis. According to the company, these features improve respiratory event detection and support better assessment of respiratory effort and sleep fragmentation, helping clinicians distinguish between obstructive and central sleep apnoea, including in complex clinical cases.

Designed for repeated use, Sunrise Air features a rechargeable system without disposable components and supports multi-night sleep testing. The company says this approach offers a more comprehensive understanding of sleep patterns, addressing limitations associated with single-night diagnostic assessments.

Laurent Martinot, CEO and Co-Founder of Sunrise, said the company aims to redefine home sleep diagnostics by combining clinical-grade accuracy with convenience. He noted that the ability to conduct multi-night monitoring could strengthen diagnostic precision while making sleep care more accessible.

The launch follows growing recognition for Sunrise’s sleep diagnostic technologies. The company’s earlier sleep assessment device has received industry recognition, including the iF Design Award, while Sunrise has also earned acknowledgments from the National Sleep Foundation and CES Innovation Awards.

The FDA clearance announcement comes shortly after Sunrise secured USD 29 million in funding, which will support expansion of its clinical services and investment in next-generation sleep technology development. The company also plans to strengthen operations through Dreem Health, its US-based virtual sleep clinic available across all 50 states.

Founded in 2015, Sunrise Group develops medical devices and digital health solutions focused on detecting, monitoring and managing sleep disorders. Headquartered in Belgium with offices in France and the United States, the company continues to expand its presence in sleep medicine through AI-supported technologies and virtual care platforms aimed at improving patient access to diagnosis and treatment.