FDA approves marketing of two cognitive skill tests for head trauma

After a traumatic head injury, most cognitive skills tests are done by physicians at the hospital well after the initial impact. The FDA announced it will allow the marketing of two devices capable of assessing a patient's cognitive function immediately after a suspected brain injury or concussion.

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the both medical software systems to assess cognitive function combine information from a physician on the symptoms of a head injury. ImPACT runs on a laptop or desktop computer for patients ages 12 to 59, while the ImPACT Pediatric runs on an iPad for children ages 5 to 11.

While not intended to diagnose concussions or determine treatments, these tools are intended to test cognitive skills such word memory, reaction time and word recognition, which are all affected by head injury.  The results of the test are then compared to age-match data in a database of the patient’s pre-injury baseline scores.

"These devices provide a useful new tool to aid in the evaluation of patients experiencing possible signs of a concussion, but clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game," said Carlos Peña, PhD, MS, director of the division of neurological and physical medicine devices at the FDA's Center for Devices and Radiological Health.