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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.

 

 

 
 

BrainScope One Functionality

EEG

  • 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
  • NFL SCAT
  • Other

FDA 510(K) CLEARANCE

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