On Dec. 3, 2024, Beacon Biosignals introduced FDA authorization of a predetermined change management plan (PCCP) for the Dreem 3S, a wearable EEG headband designed for sleep monitoring, permitting for steady sleep staging algorithm enhancements.
In regards to the Dreem 3S
The Dreem 3S makes use of built-in machine studying algorithms to seize electroencephalogram (EEG) information from the mind to observe sleep structure and help within the analysis of disturbed sleep. Designed to document for twenty-four hours and geared up with six electrodes, the Dreem 3S is a dry-EEG medical system that includes an built-in accelerometer to measure head motion and physique place. It collects information from a affected person’s residence and represents a clinically validated different to in-lab polysomnography. The system initially obtained FDA 510(ok) clearance in Aug. 2023.
This newest FDA authorization permits Beacon Biosignals to implement updates to the system’s sleep staging algorithm with out requiring a brand new 510(ok) software. The PCCP permits the corporate to refine and combine new machine studying algorithms powering the Dreem 3S system. The PCCP outlines a validation course of for algorithm updates, guaranteeing ongoing security and effectiveness of units within the face of change.
In accordance with the corporate’s press launch, this PCCP authorization is the primary for a sleep-focused wearable system.
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