FDA Authorizes Predetermined Change Control Plan for Sleep Wearable Dreem 3S

Beacon Biosignals announced on December 3, 2024, that the US Food and Drug Administration (FDA) authorized a Predetermined Change Control Plan (PCCP) for the groundbreaking Dreem 3S: a wearable EEG headband for sleep monitoring.¹ Dreem 3S is the first sleep wearable with an authorized PCCP.

The authorization allows Beacon to update the Dreem 3S sleep staging algorithm without requiring a new 510(k) submission, speeding up the process of improving this device.

“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,” said Alexander Chan, PhD, VP of Analytics and Machine Learning at Beacon Biosignals, in a statement. “This capability will deepen insights into sleep disorders and strengthen our ability to support therapy development in neurology, psychiatry, and beyond.”

Dreem 3S, equipped with 6 dry EEG electrodes and an accelerometer to monitor head movement and body position, was validated to perform as well or better than 5 human experts in a 2020 joint clinical study with an accuracy of 83.5% (±6.4) for the device and 86.4% (±8.0) for experts.² The lightweight device records for 24 hours and uses automated sleep staging to classify sleep patterns.³ Dreem 3S received FDA 510(k) clearance in August 2023 and since then transformed sleep monitoring with the option of in-home EEG tracking, rather than only in-lab polysomnography to assess sleep architecture.¹

With the addition of PCCP authorization, Beacon has the freedom to refine the machine learning algorithm of Dreem 3S to ensure that updates meet rigorous safety and efficacy standards. Beacon can also improve the algorithm when there are advancements in machine learning and neurotechnology.

“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,” said Jacob Donoghue, MD, PhD, CEO and co-founder of Beacon Biosignals, in a statement.

References

1. ^{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. Globe Newswire. December 3, 2024. https://www.globenewswire.com/news-release/2024/12/03/2990499/0/en/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.html. Accessed December 3, 2024.}
2. ^{FDA clears AI-assisted sleep monitoring device Dreem 3S. American Academy of Sleep Medicine. September 14, 2023. https://aasm.org/fda-clears-ai-assisted-sleep-monitoring-device-dreem-3s/. Accessed December 3, 2024.}
3. ^{Arnal, P. Pierrick Arnal, PhD: The Dreem Headband Versus Polysomnography. NeurologyLive. August 17, 2020. https://www.neurologylive.com/view/pierrick-arnal-phd-the-dreem-headband-compared-to-polysomnography. Accessed December 3, 2024.}