Sam Brusco, Associate Editor09.14.23
Beacon Biosignals has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance for its Dreem 3S headband, which features integrated machine learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and help with diagnosis of disturbed sleep.
The company said the clearance makes it equivalent to in-lab polysomnography to assess sleep staging, and that the device simplifies patient participation in clinically-validated, EEG-based sleep monitoring at home. Beacon Biosignals acquired the R&D business of Dreem in July 2023.
Maurizio Fava MD, Psychiatrist-in-Chief at Massachusetts General Hospital and Beacon Scientific Advisory Board member, told the press, "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."
Dreem 3S is the first dry-EEG medical device of its kind. It allows home EEG data collection and offers automated sleep staging according to the American Academy of Sleep Medicine (AASM) classification.
The headband was designed to record for 24 hours, is equipped with six electrodes, and has an accelerometer to measure head movement and body position. The company said a clinical usability study showed that Dreem 3S is both well-tolerated by users and generates clinical-grade data in the home.
Jacob Donoghue MD, Ph.D., 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."
The company said the clearance makes it equivalent to in-lab polysomnography to assess sleep staging, and that the device simplifies patient participation in clinically-validated, EEG-based sleep monitoring at home. Beacon Biosignals acquired the R&D business of Dreem in July 2023.
Maurizio Fava MD, Psychiatrist-in-Chief at Massachusetts General Hospital and Beacon Scientific Advisory Board member, told the press, "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."
Dreem 3S is the first dry-EEG medical device of its kind. It allows home EEG data collection and offers automated sleep staging according to the American Academy of Sleep Medicine (AASM) classification.
The headband was designed to record for 24 hours, is equipped with six electrodes, and has an accelerometer to measure head movement and body position. The company said a clinical usability study showed that Dreem 3S is both well-tolerated by users and generates clinical-grade data in the home.
Jacob Donoghue MD, Ph.D., 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."