Beacon Biosignals is thrilled to announce the milestone achievement of FDA 510(k) Clearance for the Dreem 3S, an advanced 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 easy-to-use device makes it simple for patients to participate in clinically-validated, EEG-based sleep monitoring at home, unlocking new insights into sleep physiology. Beacon Biosignals, a health technology company whose work focuses on accelerating the development of treatments for neurological, psychiatric, and sleep disorders, acquired the Research and Development business of Dreem in July 2023. The Dreem 3S provides the company yet another asset to provide rich datasets that deepen the understanding of brain activity during sleep.