Cognivue De Novo Classification Request For Cognitive Assessment Regulatory Information

061515cognivue

This document was released in June 2015 by the United States Food and Drug Administration (FDA). It is a de novo request submitted in June 2013 by Cerebral Assessment Systems seeking approval for a new class of medical devices/ tests to monitor cognitive function via a computerized cognitive assessment.  Cerebral Assessment Systems sought FDA approval for its Cognivue system under the new device class. The document includes the outcomes of clinical trials with the system to demonstrate the accuracy of the Cognivue system. The Cognivue system is prescription device that uses an individual’s score(s) on a battery . . .