Next Generation Cognitive Care

Cognivue® , from Cerebral Assessment Systems, is a first-of-its-kind, computer-based cognitive assessment tool designed to better and more easily measure brain function to detect early signs of dementia.

Service Provided by Sparton:

Cerebral Assessment Systems partnered with the design center in Pittsford, NY to obtain the comprehensive services required to bring the Cognivue product to commercialization, regulatory approval and manufacturing.  The detailed services provided by Sparton include:

Full System Design

  • Software design & development
  • Verification & validation
  • DHF creation
  • Regulatory guidance
  • de novo 510(k) creation & submission to FDA

Key Challenges

  • No predicate device exists for 510(k) submission
  • Requirements definition and measurement for cognitive function
  • Comparison of results to paper-based, standardized testing
  • Refinement of algorithm for better correlation & broader set of patients
  • Experience in Design History File (DHF) creation

End Result

Sparton’s design team provided the design controls and regulatory guidance to take an initial proof-of-concept prototype to an approved medical device in the new regulatory class of “Computerized Cognitive Assessment Aid” (882.1470).  Sparton is performing the manufacturing for this product launch for Cerebral Assessment Systems along with sustaining engineering services.

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