Beacon Biosignals Receives FDA Clearance for Dreem 3S Wearable EEG Headband Enabling At-Home Sleep Monitoring

Recently, Beacon Biosignals announced that its Dreem 3S wearable EEG headband has received FDA 510(k) clearance.

This Boston-based company, Beacon Biosignals, Inc., has developed the Dreem 3S, which features integrated machine learning algorithms. This advanced wearable headband captures EEG data from the brain to monitor sleep architecture and assist in diagnosing sleep disorders.

Beacon Biosignals States That Its User-Friendly Device Enables Patients to Easily Participate in Clinically Validated EEG-Based Sleep Monitoring. By Using It at Home, Patients Can Unlock New Insights into Sleep Physiology. In July This Year, Samsung Electronics Acquired the Platform by Purchasing the R&D Business of Dreem.

Traditional studies of these therapies require patients to stay overnight in a sleep lab or use less precise wrist actigraphy. According to the company,Dreem 3S is the first dry EEG medical device of its kind, capable of conveniently collecting data at home.. Patients can use the device independently, with recordings lasting up to 24 hours.

The device features six electrodes and an integrated accelerometer for measuring head movements and body position. A clinical usability study demonstrated that the Dreem 3S is not only well-tolerated by users but also capable of generating clinical-grade data in a home setting. Additionally,A recently published peer-reviewed study (Arnal et al. 2020) indicates that the Dreem 3S achieves an analytical level similar to that of PSG measurements.

Moreover, Beacon provides a scalable EEG analysis platform designed to accelerate the development of treatments in neurology, psychiatry, and sleep medicine. By combining unique data assets with machine learning algorithms, the platform identifies and standardizes neurobiomarkers to increase the probability of success at every stage of drug development.

• BeaconUsing deep learning and advanced digital signalsNumber processing to build algorithms,CanPredict the consensus of experts on EEG events more accurately and reliably than any individual expert.This makes it possible to construct high-resolution neurophysiological data and new endpoints, which tools like MRI, activity imaging, or genetic analysis cannot capture.
  

• BeaconGo beyond traditional sleep analysis to capture the neural basis of sleep physiology. In addition to extracting the gold-standard sleep staging algorithms from EEG, Beacon Biosignals' artificial intelligence can also quantify sleep microstructures (e.g., sleep spindles, arousals, etc.) to unlock new biomarkers for neurodegenerative and psychiatric disorders.

• Beacon's Datastore™ includes clinical-grade EEG data from thousands of individuals without central nervous system disorders. This standardized database accelerates the discovery of disease-specific neurobiomarkers; additionally, it allows for the extraction of custom cohorts to precisely match target patient populations. Associated metadata supports the identification of specific stratified effects and aids in the development of hybrid models with other clinical data types.

Alexander Chan, Vice President of Analytics and Machine Learning at Beacon Biosignals, stated that the algorithms of the Dreem 3S can reduce human interference. He mentioned that eliminating this disruption to existing clinical workflows enables more precise and accurate insights.

"Longitudinal EEG sleep data may be a powerful tool to help us gain deeper insights into the clinical conditions of various neurological and psychiatric disorders," said Jacob Donoghue, CEO and co-founder of Beacon Biosignals. "We are enabling high-fidelity nighttime brain activity to be effectively collected in patients' homes, opening new doors for clinical trial endpoints."

#AboutBeacon Biosignals

Beacon Biosignals was founded by MDs and engineers from Harvard University and MIT, driven by the vision of a computational platform designed to expand queries of large brain datasets with unprecedented throughput and capability. The company’s team, composed of experienced leaders in machine learning, healthcare, neuroscience, and product development, is collectively building the future of brain health.

Beacon's EEG machine learning platform supports and accelerates new treatments, transforming the lives of patients with neurological, psychiatric, or sleep disorders.Through innovative machine learning algorithms, EEG wearable devices, large clinical EEG RWE datasets, and advancements in cloud-based scientific computing technologies, Beacon Biosignals is transforming the way patients are treated for brain disorders.

Editor-in-Chief | Zhao Qing Reviewed by | Yi He Typeset by | Miya