Our Products

BrainScope One

The company’s innovative BrainScope One system (FDA cleared as Ahead 300) is an easy-to-use, non-invasive, hand-held platform that empowers physicians to make more accurate TBI 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 TBI. BrainScope One also includes digitized versions of standard clinical assessments for milder forms of TBI known as concussion.

 

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

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