Beacon Biosignals Receives FDA Approval for AI-Assisted Sleep Monitoring Device Dreem 3S

Beacon Biosignals has received FDA 510(k) Clearance for the Dreem 3S, an advanced wearable headband with integrated machine learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep.

FDA Clearance marks it as equivalent to in-lab polysomnography for the assessment of sleep staging. The easy-to-use device makes it simple for patients to participate in clinically-validated, EEG-based sleep monitoring at home, unlocking new insights into sleep physiology. Beacon Biosignals, a health technology company whose work focuses on accelerating the development of treatments for neurological, psychiatric, and sleep disorders, acquired the Research and Development business of Dreem in July 2023. The Dreem 3S provides the company yet another asset to provide rich datasets that deepen the understanding of brain activity during sleep.

The Dreem3S Advanced Wearable Headband

Maurizio Fava MD, Psychiatrist-in-Chief at Massachusetts General Hospital and Beacon Scientific Advisory Board member commented on the Dreem 3S clearance, “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.”

Sleep disorders affect millions of Americans, with strong links to underlying etiology in conditions ranging from major depressive disorder to neurodegenerative disease (Krystal, 2012). 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 (Bawany et al., 2021). 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.

The Dreem 3S medical device transforms this process. As the first dry-EEG medical device of its kind, it allows for convenient EEG data collection at home and provides automated sleep staging according to the American Academy of Sleep Medicine (AASM) classification. Patients use the device independently, from the comfort of home. The Dreem 3S is designed to record for a duration of 24 hours, is equipped with 6 electrodes, and features an integrated accelerometer to measure head movement and body position while optimizing continuous high quality data collection. A clinical usability study demonstrated that the Dreem 3S is both well-tolerated by users and produces clinical-grade data in the home environment. The Dreem 3S automated sleep staging algorithm performed as well or better than individual human experts as reported in literature (Guillot et al, 2020; Rosenberg et al, 2013).

Jacob Donoghue MD PhD, CEO and co-founder of Beacon Biosignals, emphasized the impact of the technology in clinical trials, “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 PhD, 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.”

This milestone complements Beacon Biosignals’ machine learning platform for EEG and PSG, enabling rapid analysis of large clinical neurophysiology datasets.

en_GBEnglish (UK)