On March 27, 2024, Beacon Biosignals announced it received FDA 510(k) clearance for SleepStage ML, its artificial intelligence (AI)/machine learning (ML) software that analyzes polysomnography (PSG) recordings and automatically scores sleep stages.

About SleepStage ML

According to a press release from the company, SleepStage ML leverages an advanced deep-learning model, which was trained on a massive dataset containing hundreds of thousands of hours of PSG recordings, to score sleep stages. The dataset included recordings from healthy individuals and patients with sleep disorders, neurologic disease and psychiatric disease.

SleepStage ML automates the manual sleep staging process, reducing subjective variability in scoring and supporting faster PSG analysis time. It is intended to assist in the diagnostic evaluation by a clinician to assess sleep quality from PSG recordings in a clinical setting in adult patients.

This is the first medical device in the sleep space to be FDA cleared with a Predetermined Change Control Plan (PCCP), which is a way to ensure that way to ensure that AI/ML-enabled medical devices can be safely, effectively and rapidly modified, updated and improved in response to new data. The PCCP allows Beacon Biosignals to continuously improve the sleep staging machine learning algorithm while still operating under the initial 510(k) clearance.

The FDA clearance of SleepStage ML complements Beacon Biosignals’ previous FDA clearance of the Dreem 3S wearable headband.

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