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.
