The US Food and Drug Administration (FDA) has granted 510(k) clearance for Beacon Biosignals’ Dreem 3S, a 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 device allows patients to participate in clinically validated, EEG-based sleep monitoring at home. Beacon Biosignals, a health technology company whose work focuses on accelerating the development of treatments for sleep, neurological, and psychiatric disorders, acquired the research and development business of Dreem in July.
“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,” says Maurizio Fava, MD, psychiatrist-in-chief at Massachusetts General Hospital and Beacon scientific advisory board member, in a release.
Dreem 3S, a dry-EEG medical device, provides automated sleep staging according to the American Academy of Sleep Medicine classification. Patients use the device independently. The Dreem 3S is designed to record for a duration of 24 hours, is equipped with six electrodes, and features an integrated accelerometer to measure head movement and body position while optimizing continuous 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).
“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,” says Jacob Donoghue, MD, PhD, CEO and co-founder of Beacon Biosignals, in a release.
Photo caption: The Dreem3S wearable headband
Photo credit: Beacon Biosignals / PR Newswire