BrainScope is the only FDA cleared device for structural and functional brain injuries, including concussions. The device is an easy-to-use, radiation free, hand-held platform that empowers physicians to make more accurate traumatic brain injury assessments quickly and at the point-of-care.

BrainScope’s unique system leverages advanced digital signal processing, sophisticated algorithms and machine learning technologies to identify and evaluate key brain electrical activity biomarkers of traumatic brain injuries.

BrainScope also includes digitized versions of standard clinical assessments.


Comprehensive. Accurate. Efficient.

The BrainScope device uses revolutionary EEG-based technology to identify objective markers of mild traumatic brain injury as well as the need for a CT scan.

  • Actionable answers in minutes

  • Assess the full spectrum of brain injury including functional abnormalities

  • Non-invasive

  • For patients 18-85 years of age

  • For use within 3 days of mild head injury in patients with GCS 13-15 (including concussion/mTBI)

  • Prescription (Rx-Only) Device for use by trained healthcare professional

BrainScope is not intended as a stand-alone diagnostic or to be used as a replacement for a CT scan.
Click here for complete indications and 510(k) Summary for the BrainScope One.



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BrainScope One Functionality


  • Structural Injury Classifier (SIC): Predicts the likelihood of a patient being negative or positive for brain injury on a CT scan.

  • Brain Function Index (BFI): Provides an objective marker of functional impairment that scales with severity and enables timely referrals and continuity of care.

Rapid Cognitive Performance Assessment

  • Complex Reaction Time

  • Match to Sample

Electronic Version of Standard Clinical Assessments

  • Military Acute Concussion Evaluation (MACE)

  • Concussion Symptom Inventory (CSI)

  • Grade Symptom Checklist

  • ACE- Emergency Department

  • ACE- Physician Office

  • ACE- Sports

  • SAC

  • SCAT3


  • Other