Beacon Biosignals Dreem 3S
The Dreem 3S. [Image courtesy of Beacon Biosignals]

Beacon Biosignals announced today that it received FDA 510(k) clearance for its Dreem 3S wearable electroencephalogram (EEG) headband.

The Boston-based company developed Dreem 3S with integrated machine learning algorithms. The advanced wearable headband captures EEG data from the brain to monitor sleep architecture and aid in diagnosing disturbed sleep.

Beacon Biosignals says its easy-to-use device makes it simple for patients to participate in clinically validated EEG-based sleep monitoring. By using it at home, patients can unlock new insights into sleep physiology. The company acquired the platform by buying the R&D business of Dreem in July.

Traditional research for these types of therapies requires patients to spend nights in sleep laboratories or use less-precise wrist actigraphy. Dreem 3S — the first dry-EEG medical device of its kind — allows for convenient data collection at home. Patients use the device independently, with recordings lasting for 24 hours.

The device features six electrodes and an integrated accelerometer to measure head movement and body position. A clinical usability study showed that users tolerated the device well. Dreem 3S also produced clinical-grade data in a home environment.

Alexander Chan, VP of analytics and machine learning at Beacon Biosignals, said the algorithms for Dreem 3S can reduce human variability. Doing away with this disruption to existing clinical workflows can enable more precise, accurate insights going forward, he said.

“Longitudinal EEG sleep data may be a powerful tool to gain clinical insight into a wide variety of neurological and psychiatric conditions,” said Jacob Donoghue, CEO and co-founder 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.”