Beacon Biosignals has received FDA authorization for a Predetermined Change Control Plan (PCCP) for its Dreem 3S wearable EEG headband, a device used for sleep monitoring. This authorization, announced December 3, 2024, marks a significant step in advancing sleep technology, enabling the company to rapidly improve the device's sleep staging algorithm without the need for repeated 510(k) submissions.
Streamlining Algorithm Updates
The PCCP allows Beacon Biosignals to integrate machine learning advancements into Dreem 3S more efficiently. According to Alexander Chan, PhD, VP of Analytics and Machine Learning at Beacon Biosignals, this capability will ensure greater accuracy and reliability in sleep staging, deepening insights into sleep disorders and strengthening support for therapy development in neurology and psychiatry.
Dreem 3S: Technology and Validation
Dreem 3S features 6 dry EEG electrodes and an accelerometer to monitor head movement and body position. A 2020 clinical study validated the device, demonstrating an accuracy of 83.5% (±6.4) in sleep staging, comparable to the 86.4% (±8.0) accuracy achieved by human experts. The device, which received FDA 510(k) clearance in August 2023, records data for 24 hours and uses automated sleep staging to classify sleep patterns, offering an alternative to in-lab polysomnography for assessing sleep architecture.
Impact on CNS Disease Management
With the PCCP authorization, Beacon Biosignals can refine the Dreem 3S algorithm to meet safety and efficacy standards, incorporating advancements in machine learning and neurotechnology. Jacob Donoghue, MD, PhD, CEO and co-founder of Beacon Biosignals, stated that the increasingly sophisticated AI powering Dreem 3S positions the device to transform the patient journey for millions affected by serious CNS diseases, such as major depressive disorder, where assessing disturbed sleep is central to better diagnosis and treatment decisions.
