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Sunrise Group receives FDA clearance for home sleep test

Sunrise Group receives FDA clearance for home sleep test

NEW YORK – Sunrise Group has received clearance from the U.S. Food and Drug Administration (FDA) for its Sunrise Air home sleep test. This clearance marks a major step forward in Sunrise’s mission to expand access to high-quality sleep care by providing a best-in-class, convenient, and clinically robust sleep apnea diagnostic solution that can be completed entirely at home, the company says. “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, CEO and co-founder 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.” 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 comprehensive sleep report for clinician review, the company says. The announcement comes on the heels of a $29 million raise to support the expansion of the company's clinical services and accelerate its investment in next-generation sleep technology.

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