Beacon Biosignals, a pioneering health technology company based in Boston, is making significant strides in sleep analysis with the recent FDA clearance of SleepStageML. This groundbreaking advancement expands the company’s capabilities beyond at-home sleep monitoring to encompass comprehensive coverage of traditional in-lab polysomnography (PSG).

The FDA’s 510(k) clearance for SleepStageML marks a pivotal moment for Beacon Biosignals. This advanced machine learning software utilizes electroencephalogram (EEG) signals from clinical PSG recordings to automatically stage sleep, aiding in the diagnosis and evaluation of various sleep disorders. By offering a precise and efficient solution, SleepStageML is set to revolutionize the field of sleep medicine.

Importantly, this FDA clearance complements Beacon Biosignals’ existing portfolio, which includes the Dreem 3S wearable headband and integrated algorithms. Together, these technologies provide a comprehensive solution for accurately measuring sleep architecture across different settings, whether in the comfort of one’s home or in a clinical environment.

Jacob Donoghue, MD, PhD, CEO of Beacon Biosignals, emphasizes the significance of these clearances, stating, “With FDA approvals for both SleepStageML and the Dreem 3S™ headband, Beacon now offers unmatched capabilities for measuring sleep physiology, regardless of where studies are conducted.”

One of the key benefits of SleepStageML is its ability to automate the labor-intensive manual sleep staging process, reducing subjective variability in scoring between human experts and supporting faster PSG analysis. Brandon Westover, MD, PhD, co-founder of Beacon Biosignals, highlights the impact of the advanced algorithms, stating, “These algorithms not only reduce scoring variability but also increase the precision of sleep measurements.”

What sets SleepStageML apart is its status as the first FDA-cleared sleep device with a Predetermined Change Control Plan (PCCP). This regulatory milestone allows Beacon Biosignals to continuously enhance the machine learning algorithm while ensuring safety and efficacy standards are met. This iterative approach promises ongoing improvements in sleep staging capabilities over time.

Alexander Chan, PhD, VP of Analytics and Machine Learning at Beacon Biosignals, underscores the significance of this regulatory pathway, stating, “SleepStageML’s approved PCCP represents a game-changing development for the sleep field, enabling us to provide even more accurate and robust sleep staging capabilities over time.”

In addition to its regulatory achievements, Beacon Biosignals is committed to leveraging its powerful machine learning platform to analyze large neurophysiology datasets. This positions the company as a premier technology partner for pharmaceutical companies, research institutions, and clinical trial organizations seeking to integrate high-fidelity brain monitoring and sleep measurement into their research programs.

As Beacon Biosignals continues to innovate in the field of sleep medicine, it remains dedicated to its mission of transforming the lives of patients with neurological, psychiatric, and sleep disorders.

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