FDA approves Beacon Biosignals’ headset that uses AI to monitor and improve sleep quality

Beacon Biosignals, FDA approval, neurological disorders, Artificial Intelligence

Beacon Biosignals has achieved an impressive milestone shortly after acquiring EEG headset manufacturer Dreem. The company has received FDA clearance for a sleep monitoring solution that combines Dreem’s hardware with Beacon’s own artificial intelligence (AI)-based software. This innovative sleep monitoring system is not primarily intended for individual diagnosis of sleep disorders by doctors; instead, it targets clinical research teams working on the development of treatments for various brain-related conditions.

“Longitudinal EEG sleep data may be a powerful tool to gain clinical insight into a wide variety of neurological and psychiatric conditions. We are enabling high-fidelity, overnight brain activity to be efficiently collected in the patient’s home, opening new doors for clinical trial endpoints.”

– Jacob Donoghue MD PhD, CEO and co-founder of Beacon Biosignals

When the hardware and software are combined, the resulting Dreem 3S system provides clinical researchers with a comprehensive tool for sleep monitoring and analysis. Artificial intelligence algorithms automatically calculate specific endpoints during the recording period and generate reports displaying findings for individual participants and the entire study cohort.

Beacon asserts that its AI can produce analyses equal to or better than those performed by human experts. Additionally, the system’s ability to be used in a participant’s own home eliminates the need for overnight stays in unfamiliar sleep labs or reliance on less accurate at-home wrist monitors.

“The advanced machine learning algorithms of the Dreem 3S will be instrumental in reducing the human variability that is present within existing clinical workflows, allowing for more precise, accurate insights for driving forward therapy development for sleep and sleep-related disorders.”

– Alexander Chan PhD, Beacon’s Vice President of Analytics and Machine Learning

Beacon submitted its FDA clearance application in mid-July, shortly after announcing the acquisition of Dreem’s R&D business, although the financial details of the acquisition were not disclosed. The acquisition was accompanied by an undisclosed funding round from Beacon’s existing group of investors, led by General Catalyst. This development positions Beacon Biosignals at the forefront of sleep monitoring technology, offering a promising solution for clinical research and therapy development in the field of sleep disorders and neurological conditions.

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