Beacon Receives FDA Approval for Dreem 3S; Facilitates Collection of High Quality Sleep Data in the Home Setting

Beacon Biosignals has received FDA approval for its Dreem 3S artificial intelligence-assisted sleep monitoring device through the 510(k) clearance pathway. This device is a wearable headband, equipped with advanced machine learning algorithms, is used to monitoring sleep patterns and diagnosing sleep disruptions.
The Dreem 3S is the world’s first dry-EEG medical device, enabling the convenient collection of essential brain electroencephalogram (EEG) data within the comfort of one’s home. This technology can help eliminate the need for cumbersome and costly in-laboratory sleep studies.
Designed in accordance with the standards established by the American Academy of Sleep Medicine, the device leverages automated sleep staging to accurately categorize sleep patterns. This ensures clinicians receive precise and dependable data for assessment and diagnosis, ultimately leading to more effective treatment strategies. The device is Equipped with six electrodes and has an integrated accelerometer for measuring head and body movements. A built in 24-hour recorder offers a comprehensive overview of sleep behavior and patterns.
In a recent clinical usability trial, users demonstrated high tolerance for the Dreem 3S, citing its comfort and user-friendliness. Importantly, the device consistently generated clinical-grade data, confirming its real-world effectiveness. The clinical investigation was conducted to compare the sleep staging output of the Dreem 3S device with a 510(k)-cleared PSG (Polysomnography) system in a sleep laboratory setting. The study involved 38 subjects and included a total of 36,447 sleep epochs, equivalent to approximately 303 hours and 43 minutes of sleep data. The study showed high agreement between the Dreem 3S device and expert-scored PSG for different sleep stages including 88.5% concordance when awake, 58% concordance with N1 (Stage 1), 83.4% concordance with N2 (Stage 2), 98.2% concordance with N3 (Stage 3), and 91.6% concordance with Rapid Eye Movement (REM).
Jacob Donoghue, CEO and co-founder of Beacon Biosignals, emphasized the transformative potential of the Dreem 3S, stating, “Longitudinal EEG sleep data may be a powerful tool to gain clinical insight into a wide variety of neurological and psychiatric conditions. We enable high-fidelity, nocturnal brain activity to be efficiently captured in the patient’s home, broadening clinical trial endpoints.”
It is estimated that 50-70 million individuals in the United States have sleep disorders.