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

As of June 2025, the Dreem 3S is marketed as Waveband, cleared by the FDA under 510(k) K223539. This change is in name only and does not affect the device's FDA 510(k) status, safety, usability, or performance specifications.

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.

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.

Sources:

FDA 510(k) Cleared Details

Share this post: