FDA clears ImPACT’s computerized cognitive tests for concussion assessment

The FDA awarded ImPACT Applications de novo clearance for two new devices to evaluate a patient’s cognitive function following a suspected brain injury or concussion. While the devices are not meant to diagnose concussion or determine its treatment, they will be included in the medical evaluation for head injury.

The devices, dubbed the ImPACT (Immediate Post-Concussion Assessment and Cognitive Test) and ImPACT Pediatric, are computerized tests that assess cognitive skills that a head injury could affect, such as word memory, reaction time and word recognition, according to an FDA statement. Scores would be compared against an age-matched control database or to pre-injury baseline scores if available for the patient.

The ImPACT software is cleared for patients aged 12 to 59, and runs on a desktop or laptop computer. The pediatric version is cleared for those aged 5 to 11 and runs on a tablet.

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