Sunrise receives FDA clearance for rechargeable at-home sleep testing device. Wednesday, May 20, 2026 Sunrise Group has received clearance from the U.S. Food and Drug Administration for Sunrise Air, the latest version of its at-home sleep testing device designed to diagnose sleep apnoea. The approval marks a major step in the company's efforts to improve access to sleep care through a home-based diagnostic solution that combines convenience with clinical-level analysis. Obstructive sleep apnoea affects more than 900 million people worldwide, but many cases remain undiagnosed because of limited access to sleep laboratories and long waiting periods for traditional polysomnography testing. Sunrise Air uses a lightweight chin-worn sensor to record mandibular jaw movements, a clinically validated biosignal used in sleep assessment. The collected data is analysed using artificial intelligence-supported algorithms to create a detailed sleep report for clinicians. The new device expands on the company's existing mandibular jaw movement technology by adding thermistors for airflow monitoring, an optical module for oxygen saturation and pulse rate measurement, and an embedded microphone for snoring analysis. These additions are intended to improve the detection of respiratory events and support better differentiation between obstructive and central sleep apnoea. The rechargeable device is designed for multi-night testing and does not require disposable components. According to the company, the system aims to provide laboratory-quality sleep analysis in a more patient-friendly format that can be completed entirely at home. Sunrise recently received the iF Design Award for the device's lightweight design and agreement with polysomnography results. The company has also been recognised by the National Sleep Foundation and the CES Innovation Awards. The announcement follows Sunrise's recent $29 million funding round, which will support the expansion of its clinical services through Dreem Health, the company's virtual sleep clinic in the United States, and further investment in sleep technology development.

🎉 𝐓𝐨𝐝𝐚𝐲, 𝐰𝐞 𝐜𝐞𝐥𝐞𝐛𝐫𝐚𝐭𝐞 𝐚 𝐡𝐮𝐠𝐞 𝐬𝐭𝐞𝐩 𝐟𝐨𝐫𝐰𝐚𝐫𝐝 𝐢𝐧 𝐬𝐥𝐞𝐞𝐩 𝐡𝐞𝐚𝐥𝐭𝐡: 𝐒𝐮𝐧𝐫𝐢𝐬𝐞 𝐡𝐚𝐬 𝐫𝐚𝐢𝐬𝐞𝐝 $𝟐𝟗𝐌 𝐢𝐧 𝐧𝐞𝐰 𝐟𝐮𝐧𝐝𝐢𝐧𝐠. This new round was led by Eurazeo and joined by Seventure Partners, INVESTSUD, and Noshaq alongside the continued support of our existing investors: Amazon Alexa Fund, WE International, Kurma Partners, Vives Fund, Majycc Innovation Santé - UI Investissement, NAMUR INVEST, Sambrinvest, IMBC and invest.bw. With this support, Sunrise will: ✨ Expand Dreem Health | Sunrise, our digital sleep clinic, now live in all 50 U.S. states ✨ Build advanced hardware & software to better detect, monitor, and treat sleep disorders ✨ Prepare the next phase of our strategy in Europe Most of all, this milestone is a testament to our team — clinicians, engineers, researchers, and a whole team working every day to make expert sleep care faster, simpler, and accessible to all. 𝐓𝐡𝐢𝐬 𝐦𝐢𝐥𝐞𝐬𝐭𝐨𝐧𝐞 𝐛𝐞𝐥𝐨𝐧𝐠𝐬 𝐭𝐨 𝐲𝐨𝐮 💙 #SleepHealth #DigitalHealth #HealthTech #Innovation #Healthcare | 35 comments on LinkedIn