Beacon Biosignals turns at-home EEG and other biosignal data into AI-driven tools for drug development and sleep diagnostics. Its Waveband headband, formerly Dreem 3S, is FDA 510(k)-cleared and supports clinical-grade sleep monitoring outside the lab, while the company’s platform helps research teams identify biomarkers and measure treatment effects. Beacon says its technology has supported more than 40 clinical trials, analyzed over 2 million hours of EEG, and completed 500,000 home sleep tests.
FDA 510(k) clearance
FDA clearance
SOC 2 Type 2 certification
Compliance program
US DPF registration
Registration
AASM compliance
Compliance program
CMS compliance
Compliance program
HIPAA-compliant cloud platform
Compliance program
CMS
Quality certification
DormotechDormotech develops wireless hardware, clinical software, and cloud infrastructure for comprehensive sleep diagnostics in both patients’ homes and attended laboratories. Its DormoVision X™ platform connects 38-channel home and in-lab polysomnography within one review and reporting workspace, with the company reporting 96.6% agreement with traditional attended Type I PSG in clinical validation. Dormotech also offers a research platform for multichannel sleep data and machine-learning analysis.YOUNGSTOWN, OH
General Sleep CorporationEstablished in Cleveland in 1992, General Sleep Corporation is a medical-device developer known for applying EEG to the study of sleep and sleep disorders. Its Zmachine technology supports clinical and research work, including at-home monitoring, for licensed healthcare and research professionals rather than patients directly. The company holds patents related to insomnia treatment, brainwave analysis, and signal processing.CLEVELAND, OH
BrainScope Company, IncFounded in 2006, BrainScope develops medical neurotechnology that converts brain electrical activity (EEG) into objective, point-of-care assessments for brain health. Its FDA-cleared system was the first AI/machine-learning medical device cleared in neurology and is used to assess head injuries for the likelihood of brain bleeds and concussion without radiation. The company is now extending its EEG-based platform into digital biomarkers for conditions including stroke and cognitive decline.ROCKVILLE, MD
Bio-Signal Group CorpFounded in 2002 by NYU neuroscientist André Fenton, Bio-Signal Group Corp. develops portable neurodiagnostic equipment and software that bring clinical-grade EEG testing beyond the traditional hospital lab. Its FDA-cleared microEEG® system can be set up in about five minutes without a specialized EEG technician, with cloud-based interpretation enabling board-certified neurologists to read studies remotely in less than an hour. The company’s work serves settings ranging from emergency departments and physician practices to sports concussion management.BROOKLYN, NY