FDA Approves Devices for Assessing Cognitive Function After Brain Injury

fdalogoThis week the Food and Drug Administration (FDA) has approved two computerized cognitive tests that can assess cognitive skills immediately following a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.

According to the FDA, “ImPACT and ImPACT Pediatric are not intended to diagnose concussions or determine appropriate treatments. Instead the devices are meant to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury. The results are compared to an age-matched control database or to a patient’s pre-injury baseline scores, if available.

ImPACT software runs on a desktop or laptop and is intended for use with those aged 12 to 59. The ImPACT Pediatric runs on an iPad and is designed for children aged 5 to 11. The FDA reviewed ImPACT through its de novo classification process, a regulatory pathway for novel, low- to-moderate-risk medical devices that are first of a kind and for which there are special and general controls to provide a reasonable assurance of safety and effectiveness of the devices.

FDA Announcement
ImPACT Applications

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