Beacon Biosignals announced in a press release on Sep. 13, 2023 that it received FDA 510(k) clearance for the Dreem 3S, an artificial intelligence (AI)-assisted wearable headband for sleep monitoring. The device allows patients to participate in home-based electroencephalogram (EEG) data collection.
About the Dreem 3S
According to the company, the Dreem 3S uses integrated machine learning algorithms to capture EEG data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep. Patients can use the device independently from home.
The Dreem 3S is designed to record for 24 hours. It features six electrodes and an integrated accelerometer to measure head movement and body position. It uses automated sleep staging to classify sleep patterns.
The lightweight, low-profile device represents an alternative to in-laboratory polysomnography. Beacon Biosignals notes that the Dreem 3S is the first dry-EEG medical device of its kind.
About sleep disorders
Sleep disorders are conditions that disrupt normal sleep patterns, affecting the quality, amount and timing of sleep. With an estimated 70 million people worldwide experiencing sleep disorders, these conditions can contribute to physical and mental health problems.
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