Sunrise Group has secured the US Food and Drug Administration (FDA) clearance for Sunrise Air, its latest rechargeable at-home sleep test.
This development advances Sunrise’s efforts to broaden access to sleep diagnostics through clinically robust, at-home solutions for sleep apnoea assessment.
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The company stated that obstructive sleep apnoea (OSA) affects more than 900 million people worldwide, with many underdiagnosed due to restricted access to sleep laboratories and prolonged waits for traditional polysomnography (PSG).
Sunrise addresses these challenges with a lightweight, at-home sensor that records mandibular jaw movements (MJM), a validated biosignal for sleep evaluation.
Proprietary AI algorithms analyse the collected data and present comprehensive sleep reports for clinicians.
Sunrise Air extends the MJM technology with new features, including thermistors for airflow measurement, an optical sensor for oxygen saturation and pulse rate, and an in-built microphone for refined snoring analysis.
These technical enhancements bolster the device’s ability to detect respiratory events and differentiate between central and obstructive apnoeas, even in complex clinical cases.
Ergonomically designed for comfort, Sunrise Air is ultra-light and fully rechargeable, enabling flexible, multi-night sleep studies without disposable parts.
It aims to deliver laboratory-level data in a patient-friendly and accessible format, removing many of the limitations present in traditional sleep laboratories.
Sunrise CEO and co-founder Laurent Martinot said: “Sunrise has already set a new benchmark for home sleep testing through its high level of diagnostic accuracy even across complex sleep apnoea phenotypes, including central sleep apnoea, supported by its unique ability to measure respiratory effort.
“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.”
The FDA clearance follows Sunrise’s recent $29m funding, which is aimed at expanding clinical services via US-based virtual sleep clinic Dreem Health.
