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.

It utilises deep-learning to automatically stage sleep from electroencephalogram (EEG) signals in clinical polysomnography (PSG) recordings.

The software’s deep-learning model was trained on a substantial dataset comprising hundreds of thousands of hours of PSG recordings from a diverse patient population.

Clinical validation has shown that SleepStageML’s performance is on par with or surpasses that of individual human experts.

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Some of the benefits of SleepStageML include reducing variability in human scoring, automating the manual sleep staging process, and supporting quicker PSG analysis turnaround times.

A noteworthy aspect of SleepStageML’s FDA clearance is the inclusion of a Predetermined Change Control Plan (PCCP).

This approach allows the company to continuously enhance the machine learning algorithm while maintaining compliance with the original 510(k) clearance.

Beacon Biosignals analytics and machine learning vice-president Alexander Chan said: “SleepStageML’s approved PCCP is a game-changing development for the sleep field.

“With this regulatory pathway, we can provide even more accurate and robust sleep staging capabilities over time. This ability to iteratively enhance SleepStageML will be invaluable for generating insights to accelerate sleep therapy research and development.”

Last year, Beacon Biosignals obtained FDA 510(k) clearance for its AI-assisted sleep monitoring device, Dreem 3S.

Beacon Biosignals CEO Jacob Donoghue said: “With FDA clearances for both SleepStageML and Dreem 3S headband, Beacon now provides an unparalleled capability to measure sleep physiology whether studies are conducted in-home or in-clinic.

“Beacon’s powerful analytics platform allows for a rich analysis of clinical datasets across multiple environments to spur innovation in therapies for sleep disorders as well as neurological and psychiatric conditions with sleep comorbidities.”


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