FDA Authorizes Beacon’s Dreem 3S as First Sleep Wearable with Predetermined Change Control Plan, Paving the Way for Continuous Algorithm Enhancements in Sleep Monitoring

BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) — Beacon Biosignals is proud to announce FDA authorization of the Predetermined Change Control Plan (PCCP) for the Dreem 3S, a groundbreaking wearable EEG headband designed for sleep monitoring. This authorization enables Beacon to implement updates to the Dreem 3S sleep staging algorithm without requiring a new 510(k) submission, accelerating the development of improved capabilities for this advanced medical device.

The Dreem 3S, which originally received FDA 510(k) clearance in August 2023, has already transformed sleep monitoring with its in-home EEG capabilities, offering a clinically validated alternative to in-lab polysomnography for assessing sleep architecture. Now, this PCCP authorization, the first for a sleep-focused wearable device, allows Beacon to further refine the machine learning algorithms powering Dreem 3S, ensuring that updates meet rigorous safety and efficacy standards while keeping pace with advancements in machine learning and neurotechnology. Earlier this year, Beacon received the FDA’s first PCCP authorization for a sleep-related medical device with its SleepStageML™ AI software, which can autoscore and analyze signals acquired from any EEG or polysomnograph.

Jacob Donoghue, MD, PhD, CEO and co-founder of Beacon Biosignals, commented:

“With increasingly sophisticated AI powering the Dreem 3S medical device, Beacon is poised 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.”

The Predetermined Change Control Plan outlines a stringent validation process for algorithm updates, guaranteeing that any changes are rigorously tested against clinical performance benchmarks. This framework allows Beacon to address evolving scientific knowledge, improve patient outcomes, and adapt to the needs of researchers and clinicians without additional regulatory submission.

Alexander Chan, PhD, VP of Analytics and Machine Learning at Beacon Biosignals, emphasized:

“With the PCCP in place, we can rapidly integrate new advancements in machine learning into Dreem 3S, ensuring even greater accuracy and reliability in sleep staging. This capability will deepen insights into sleep disorders and strengthen our ability to support therapy development in neurology, psychiatry, and beyond.”

The Dreem 3S headband, equipped with six dry-EEG electrodes and an accelerometer for head movement and body position monitoring, collects clinical-grade EEG data in the comfort of the patient’s home. The device’s AI-driven sleep staging capabilities have already been validated to perform as well or better than human experts. The newly approved PCCP ensures the ongoing enhancement of these capabilities, reinforcing Beacon’s leadership in clinical-grade EEG analytics and sleep research.

The PCCP authorization also complements Beacon’s broader machine learning platform for EEG analysis, which supports research and clinical trials for neurological, psychiatric, and sleep-related disorders.

Potential collaborators interested in incorporating Dreem 3S and its evolving algorithmic capabilities into clinical trials are encouraged to contact Beacon Biosignals via https://beacon.bio/contact.

About Beacon Biosignals

Beacon Biosignals is a health technology company transforming the development of treatments for neurological, psychiatric, and sleep disorders. With advanced machine learning, wearable EEG devices, large real-world neurophysiology datasets, and multiple FDA clearances, Beacon accelerates insights into brain activity to improve patient outcomes. For more information, visit https://beacon.bio.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4457a080-bc24-4006-b2b8-395a3454f4ce

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