Neuronetrix, Inc.


Neuronetrix, founded in 2003 by John H. Barker, MD and Kalford C. Fadem, specializes in neuroscience research and clinical applications of EEG and ERP technologies. The company develops and markets the COGNISION® System, a portable, easy-to-use neurodiagnostic device designed for clinical, research, and trial settings to assess cognitive function and brain activity. Their mission is to provide scientifically validated, scalable, and practical solutions for diagnosing and researching cognitive disorders such as Alzheimer’s disease, concussion, and other neurological conditions, with a focus on enhancing early diagnosis, treatment, and drug development.

Industries

clinical-trials
health-care
medical-device
pharmaceutical

Nr. of Employees

small (1-50)

Neuronetrix, Inc.


Products

Portable EEG/ERP acquisition and analytics system

A portable, battery-powered multi-channel EEG/ERP acquisition system combined with cloud-based analytics that records electrophysiological responses to standardized stimuli, performs automated preprocessing and analysis, and produces clinician-facing reports for use in clinical assessment, cognitive research, and clinical trials.

Cloud analytics and clinical trial software suite

Cloud-hosted software that automates data upload, preprocessing, statistical analysis, generates reports, and integrates CTMS/eCRF functionality to support adaptive study designs and near-real-time monitoring.


Services

Deployment and operational support for ERP/qEEG biomarker collection in multi-center clinical trials, including remote monitoring, near-real-time visibility to data and statistics, automated upload to cloud database, CTMS/eCRF integration, and 24/7 site support.

Onboarding, training, and operational support for clinician offices and memory clinics, plus rental/deployment models and assistance related to billing and reimbursement coding.

Support for academic and cross-cultural research studies including provision of portable acquisition hardware, protocol development tools, cloud-based data sharing for multi-center studies, and automated analysis pipelines.

Expertise Areas

  • Electrophysiology for cognitive assessment (EEG/ERP)
  • Clinical biomarker validation and multi-center studies
  • Clinical trial endpoint implementation for CNS drugs
  • Cloud-based clinical data management and CTMS integration
  • Show More (4)

Key Technologies

  • Quantitative EEG (qEEG)
  • Event-related potentials (ERP)
  • Wireless, battery-powered EEG headsets
  • Active electrodes and low-impedance biosensors
  • Show More (6)

News & Updates

Neuronetrix announced the U.S. clinical launch of the COGNISION™ System at the Alzheimer’s Association International Conference in 2015, aimed at improving early diagnosis of Alzheimer’s disease.

Neuronetrix received FDA 510(k) clearance in 2015 to market the COGNISION™ System for clinical use, enabling primary care physicians to perform EEG and ERP tests in-office.

Neuronetrix presented research on electrophysiological measures in Alzheimer’s disease at the 2015 AAIC conference, showcasing the clinical utility of COGNISION®.

Peer-reviewed validation studies demonstrating the reliability and sensitivity of COGNISION® biomarkers in detecting cognitive disorders and drug effects.

Multiple peer-reviewed papers and clinical studies validating the use of COGNISION® for early detection and monitoring of Alzheimer’s disease.

Received FDA 510(k) clearance in 2015 to market the COGNISION™ System for clinical use.

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