The FDA approved the predetermined change control plan (PCCP) for Dreem 3S enabling a sleep staging algorithm update without requiring a new 510(k) submission. This accelerates the development of improved capabilities for the medical device, Beacon Biosignals said.
Boston-based Beacon designed Dreem 3S with integrated machine-learning algorithms. The advanced wearable headband captures EEG data from the brain to monitor sleep architecture and aid in diagnosing disturbed sleep. It received FDA clearance in September 2023.
Beacon Biosignals says its easy-to-use device makes it simple for patients to participate in clinically validated EEG-based sleep monitoring. By using it at home, patients can unlock new insights into sleep physiology. Dreem 3S — the first dry-EEG medical device of its kind — allows for convenient data collection at home, according to the company. Patients use the device independently, with recordings lasting for 24 hours.
The device features six electrodes and an integrated accelerometer to measure head movement and body position. A clinical usability study showed that users tolerated the device well. Dreem 3S also produced clinical-grade data in a home environment.
Beacon Biosignals says the latest FDA authorization allows it to further refine machine learning algorithms that power Dreem 3S.
“With increasingly sophisticated AI powering the Dreem 3S medical device, Beacon is poised to transform the patient journey for millions affected by serious CNS diseases, such as major depressive disorder, where assessing disturbed sleep is central to better diagnosis and treatment decisions,” said Dr. Jacob Donoghue, CEO and co-founder of Beacon Biosignals.
