On Dec. 3, 2024, Beacon Biosignals announced FDA authorization of a predetermined change control plan (PCCP) for the Dreem 3S, a wearable EEG headband designed for sleep monitoring, allowing for continuous sleep staging algorithm enhancements.
About the Dreem 3S
The Dreem 3S uses integrated machine learning algorithms to capture electroencephalogram (EEG) data from the brain to monitor sleep architecture and aid in the diagnosis of disturbed sleep. Designed to record for 24 hours and equipped with six electrodes, the Dreem 3S is a dry-EEG medical device featuring an integrated accelerometer to measure head movement and body position. It collects data from a patient’s home and represents a clinically validated alternative to in-lab polysomnography. The device originally received FDA 510(k) clearance in Aug. 2023.
This latest FDA authorization allows Beacon Biosignals to implement updates to the device’s sleep staging algorithm without requiring a new 510(k) application. The PCCP allows the company to refine and integrate new machine learning algorithms powering the Dreem 3S device. The PCCP outlines a validation process for algorithm updates, ensuring ongoing safety and effectiveness of devices in the face of change.
According to the company’s press release, this PCCP authorization is the first for a sleep-focused wearable device.
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