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BrainScope One


Comprehensive. Accurate. Efficient.

The BrainScope One brain injury assessment device uses revolutionary EEG-based technology that facilitates confident decision-making on the spot.

  • 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 One 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 EEG Assessment

  • Brain Function Index EEG Assessment

Rapid Cognitive Performance Assessment (performed by patient)

  • 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

Cleared on September 22, 2016 as "Ahead 300" under K161068

Subsequent labeling modification to clarify device capabilities with regard to "concussion/mTBI" in the
Indications for Use cleared on May 18, 2018 under K181179

Please contact us with additional questions at CustomerCare@Brainscope.com or 1-855-927-2461