US-based Beacon Biosignals has received the US Food and Drug Administration (FDA) 510(k) clearance for its advanced wearable headband Dreem 3S to capture electroencephalogram (EEG) data from the brain.
Dreem 3S is an artificial intelligence (AI)-assisted sleep monitoring device with integrated machine learning algorithms.
Beacon Biosignals has designed the device to monitor sleep architecture and support the diagnosis of disturbed sleep.
The FDA clearance marks the device equivalent to in-lab polysomnography for the evaluation of sleep stages.
According to health technology firm, the user-friendly device enables patients to easily participate in clinically validated, EEG-based sleep monitoring at home, providing new insights into sleep physiology.
The Dreem 3S medical device, claimed as the first dry-EEG medical device of its kind, allows easy EEG data collection at home. It also offers automatic sleep staging in accordance with the American Academy of Sleep Medicine (AASM) classification, the company said.
Beacon Biosignals said that Dreem 3S is designed to record for a duration of 24 hours while maximising continuous high quality data collection.
The wearable headband can be used independently, from the comfort of home. It is said to have six electrodes and an inbuilt accelerometer to assess head movement and body position.
Beacon Biosignals CEO and co-founder Jacob Donoghue said: “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.”
In July 2023, Dreem’s research and discovery division was bought by Beacon Biosignals.
According to a clinical usability study, the sleep monitoring device produces clinical-grade data in the home environment and is well tolerated by users.
Its automated sleep staging algorithm outperformed individual human specialists, the health technology company said.
The Dreem 3S is said to give Beacon Biosignals one more tool to offer rich datasets that advance the firm’s understanding of brain activity during sleep.
