Beacon Biosignals announced the presentation of new data supporting the use of its EEG headband for monitoring sleep. Boston-based Beacon Biosignals designed its Dreem 3S headband with integrated machine-learning algorithms. The advanced wearable headband features six electrodes and an integrated accelerometer to measure head movement and body position. Itcaptures EEG data from the brain to […]
Beacon Biosignals
FDA authorizes sleep wearable algorithm updates from Beacon Biosignals
Beacon Biosignals announced today that it received FDA authorization for a new update to its Dreem 3S wearable sleep monitoring headband. 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 […]
FDA clears sleep monitoring software from Beacon Biosignals
Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring. SleepStageML automatically stages sleep from electroencephalogram (EEG) signals of clinical polysomnography (PSG) recordings. It aids in the diagnosis and evaluation of sleep and sleep-related disorders. Boston-based Beacon Biosignals said in a news release that the software could enable […]
Beacon Biosignals wins FDA nod for wearable sleep monitor
Beacon Biosignals announced today that it received FDA 510(k) clearance for its Dreem 3S wearable electroencephalogram (EEG) headband. The Boston-based company developed 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. Beacon Biosignals says its easy-to-use device makes […]
