FDA Approves Beacon Biosignals’ AI-Assisted Sleep Monitoring Device

Image Credit: Adobe Stock Images/Andrey Popov

Beacon Biosignals revealed that they have been approved for the FDA 510(k) clearance on the Dreem 3S, its 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. The approval comes amid Beacon Biosignals’ acquisition of Dreem this past June.

"Longitudinal EEG sleep data may be a powerful tool to gain clinical insight into a wide variety of neurological and psychiatric conditions,” said Jacob Donoghue, MD, PhD, CEO, co-founder, Beacon Biosignals. “We are enabling high-fidelity, overnight brain activity to be efficiently collected in the patient's home, opening new doors for clinical trial endpoints."

Reference: Beacon Biosignals Receives FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S. PR Newswire. September 14, 2023. Accessed September 14, 2023. https://www.prnewswire.com/news-releases/beacon-biosignals-receives-fda-clearance-for-ai-assisted-sleep-monitoring-device-dreem-3s-301927727.html#:~:text=BOSTON%2C%20Sept.%2014%2C%202023,monitor%20sleep%20architecture%20and%20aid