Beacon Biosignals today heralded the FDA’s approval of an updated algorithm for its Dreem 3S sleep monitoring headband. The FDA sanctioned the predetermined change control plan (PCCP) for the Dreem 3S, allowing for updates to the sleep staging algorithm without necessitating a new 510(k) application. Beacon Biosignals highlights this as a step forward in enhancing the device’s functionality.
Based in Boston, Beacon has engineered Dreem 3S with embedded machine learning algorithms. This pioneering headband gathers EEG data from the brain to assess sleep architecture, assisting in identifying sleep disturbances. It received its FDA clearance in September 2023.
According to Beacon Biosignals, the device’s straightforward design simplifies patient participation in clinically validated EEG-based sleep studies. When used at home, Dreem 3S provides novel insights into sleep dynamics, being the first dry-EEG medical device offering easy home data collection. Patients use it independently, allowing 24-hour continuous recordings.
The device is equipped with six electrodes and a built-in accelerometer to track head movements and body posture. Clinical usability trials confirmed participants found the device comfortable and it was capable of delivering clinical-grade data at home.
With the FDA’s recent approval, Beacon Biosignals plans to continue refining the machine learning algorithms that support Dreem 3S.
“Incorporating cutting-edge AI within the Dreem 3S, Beacon is set to revolutionize the patient experience for many facing critical CNS ailments like major depressive disorder, where understanding sleep disturbances plays a pivotal role in enhancing diagnosis and treatment,” stated Dr. Jacob Donoghue, CEO and co-founder of Beacon Biosignals.