Sunrise Group secures FDA clearance for home sleep test

The lightweight, at-home sensor records MJM, a validated biosignal for sleep evaluation.

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.

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).

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