FDA allows marketing of first-of-kind computerized cognitive tests

The US Food and Drug Administration (FDA) permitted marketing of two new devices to assess 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 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.

The device is manufactured by ImPACT Applications, located in Pittsburgh, Pennsylvania, USA.

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.


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