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Beacon obtains FDA clearance for SleepStageML software

March 28, 2024

Beacon Biosignals has secured the US Food and Drug Administration’s (FDA) 510(k) clearance for SleepStageML, a machine learning software designed to enhance sleep analysis.

This development expands the company’s analytical capabilities, extending from at-home sleep monitoring to include in-lab polysomnography, a traditional method for diagnosing sleep disorders.

SleepStageML is designed to help improve the diagnosis and evaluation of sleep and sleep-related disorders.

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