Beacon Biosignals announced FDA authorization for an update to its Dreem 3S wearable sleep monitoring headband, enabling sleep staging algorithm enhancements under a predetermined change control plan (PCCP) without requiring a new 510(k) submission. This approval accelerates the development of improved capabilities for the device, the company stated.
Designed by the Boston-based company, Dreem 3S utilizes machine-learning algorithms to capture EEG data from the brain, monitor sleep architecture, and aid in diagnosing sleep disturbances. First cleared by the FDA in September 2023, the device offers an easy-to-use, clinically validated platform for home-based EEG sleep monitoring, providing patients with new insights into sleep physiology. As the first dry-EEG medical device of its kind, Dreem 3S allows independent use, with recordings lasting 24 hours.
Equipped with six electrodes and an accelerometer for tracking head movement and body position, the device has demonstrated strong user tolerance and delivered clinical-grade data in a home environment, according to a usability study. The recent FDA authorization enables further refinement of the machine learning algorithms powering Dreem 3S, enhancing its capabilities.
Dr. Jacob Donoghue, CEO and co-founder of Beacon Biosignals, emphasized the transformative potential of the device. By leveraging sophisticated AI, Dreem 3S aims to improve diagnosis and treatment decisions for patients with serious central nervous system (CNS) diseases, such as major depressive disorder, where disturbed sleep is a critical diagnostic factor.
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