FDA greenlights Beacon’s AI-assisted sleep monitoring device

Dreem 3S headband monitors sleep architecture and enables disturbed sleep diagnosis.

Healthtech company Beacon Biosignals has received FDA 510(k) clearance for the Dreem 3S, a wearable headband designed to capture electroencephalogram (EEG) data from the brain. Equipped with integrated machine learning algorithms, the Dreem 3S facilitates the monitoring of sleep architecture and aids in the diagnosis of disturbed sleep.

Disturbed nighttime sleep has been linked to underlying causes in conditions ranging from major depressive disorder to neurodegenerative diseases. Additionally, it plays a substantial role in patient-reported quality of life and daytime functioning, particularly in disorders with sleep-related comorbidities like atopic dermatitis or chronic pain. Traditionally, obtaining sleep-related data for the development of novel therapies required patients to undergo overnight stays in sleep laboratories or relied on less precise surrogate measures like wrist actigraphy.

Specializing in neurological, psychiatric, and sleep disorders, Beacon Biosignals acquired the R&D business of Dreem in July 2023, adding the Dreem 3S to its arsenal of tools aimed at enhancing comprehension of brain activity during sleep. The company says the FDA clearance places Dreem 3S on par with in-lab polysomnography for assessing sleep staging. It provides a convenient means for patients to engage in clinically validated, EEG-based sleep monitoring in their own homes.

“It is very important patients suffering from disturbed nighttime sleep be accurately monitored in their natural settings,” said Dr Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital and Beacon Scientific Advisory Board member. “This new solution makes that possible and has potential to help further research and therapeutic interventions within the field.”

The Dreem 3S enables the convenient collection of EEG data at home while providing automated sleep staging. Patients can use the device independently, obviating the need for overnight hospital stays. Product features include a 24-hour recording capability, six electrodes, and an integrated accelerometer to monitor head movement and body position, all while optimizing the collection of high-quality data.

In a clinical usability study, Beacon says the Dreem 3S demonstrated user tolerability and the production of clinical-grade data in a home environment, performing on a par with or exceeding human experts.

This milestone complements Beacon’s existing machine learning platform for the rapid analysis of large clinical neurophysiology datasets. The company is now seeking potential partners and clinical trial collaborators interested in incorporating the Dreem 3S into studies related to neurology, psychiatry, sleep medicine and beyond.

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