FDA clearance given to Beacon Biosignals' AI-assisted sleep monitoring device

By Liza Laws

- Last updated on GMT

© Getty Images
© Getty Images

Related tags sleep apnea Beacon Biosignals AI Data management Patient centricity Research Artificial intelligence

An advanced wearable headband with integrated machine learning algorithms has achieved The US Food and Drug Administration’s 510(k) clearance.

Beacon Biosignals says it was thrilled to get the clearance for its Dreem 3S headband that captures electroencephalogram (EEG) data from the brain to monitor sleep architecture and help diagnose disturbed sleep.

FDA Clearance marks it as equivalent to in-lab polysomnography for the assessment of sleep staging. This means it is easy for people to take part in clinically-validated EEG-based sleep monitoring at home which could unlock new insights into sleep physiology.

Beacon Biosignals, a health technology company whose work focuses on speeding-up the development of treatments for neurological, psychiatric, and sleep disorders, acquired the research and development business of Dreem in July this year (2023).

The Dreem 3S provides the company yet another asset to provide rich datasets that deepen the understanding of brain activity during sleep.

Maurizio Fava psychiatrist-in-chief at Massachusetts General Hospital said: “It is very important patients suffering from disturbed nighttime sleep be accurately monitored in their natural settings.

“This new solution makes that possible and has potential to help further research and therapeutic interventions within the field."

In its research the company found that sleep disorders affect millions of Americans, with strong links to underlying etiology in conditions ranging from major depressive disorder to neurodegenerative disease.

Beacon Bioosignals said it discovered that while often overlooked, disturbed nighttime sleep may play a significant role in patient-reported quality of life and daytime functioning in disorders associated with sleep comorbidities, such as atopic dermatitis or chronic pain.

Traditionally, capturing sleep endpoints in the development of novel therapies requires patients to spend nights in sleep laboratories, or relies on less-precise surrogate measures of sleep activity via wrist actigraphy. 

It believes the Dreem 3S medical device transforms this process and that it is the first dry-EEG medical device of its kind and is designed to record for a duration of 24 hours. It is equipped with six electrodes and features an integrated accelerometer to measure head movement and body position while continuously collecting data.

Jacob Donoghue, CEO, and co-founder of Beacon Biosignals said: “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.”

Alexander Chan Beacon's vice president of analytics and machine Learning added: "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."

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