
FDA Clears Headband for Home EEG-Based Sleep Monitoring
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Beacon Biosignals’ Dreem 3S, a 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…