FDA-cleared products for clinical use

At BEL, we’re committed to advancing brain electrophysiology through clinically validated, easy-to-use tools. SOURCERER and NEAT are now cleared by the FDA for use in clinical environments, bringing cutting-edge science into real-world applications in neurology, sleep medicine, and clinical research.

SOURCERER is a real-time cortical source localization tool optimized for high-density EEG. Clinically validated and FDA-cleared, SOURCERER empowers clinicians and researchers to visualize and localize neural activity with anatomical precision.

  • Cortical mapping in under 10 seconds

  • Works with HD-EEG, ERP, and frequency-based signals

  • Integrated head models with MRI-free localization

  • Designed for clinical workflows

NEAT (Neurosom EEG Assessment Technology) performs automatic sleep staging from EEG data using a deep neural network AI trained on multi-site PSG datasets. It delivers AASM-compliant hypnograms and sleep statistics with high accuracy and confidence.

  • Fully automated sleep staging for MFF EEG files

  • Cleared for Sleep WISP sleep staging

  • No ECG, EOG, or EMG required

  • Built-in comparison to expert-scored gold standards

  • Outputs downloadable PDF reports

Both SOURCERER and NEAT are developed under BEL’s Quality Management System and comply with:

  • 21 CFR Part 820

  • IEC 62304 - Medical device software – software life cycle processes

  • ISO 14971 - Medical device risk management purposes

  • ISO 13485 - QMS compliance to the standard for organizations involved in the Medical Device industry

  • ISO 62366 -  Application of usability engineering to medical devices

  •  ISO 15223 -  Symbols to be used with information to be supplied by the manufacturer

Ready to bring clinical-grade EEG analysis into your practice or lab?

Contact us today to get started with SOURCERER or NEAT.


All of the BEL products are developed under BEL's quality system to meet regulatory standards.