New Medical Devices FDA-Cleared for Cognition Assessment Post-Concussion
The Food and Drug Administration (FDA) has approved the marketing of the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric medical devices to assess a patient's cognitive function immediately after a suspected brain injury or concussion.
These devices are intended for use as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury. They are not intended to diagnose concussions or to determine appropriate treatment. ImPACT and ImPACT Pediatric test cognitive skills such as word memory, reaction time, and word recognition. The patient's results are compared to an age-matched control database or to the patient's pre-injury baseline scores if they are available.
The ImPACT software is designed for individuals aged 12–59 years and the ImPACT Pediatric is designed for children aged 5–11 years. ImPACT runs on a desktop or laptop whereas ImPACT Pediatric runs on an iPad.
The manufacturer submitted research analyzing the scientific value of the ImPACT devices, including their validity, reliability, and ability to detect evidence of cognitive dysfunction that might be associated with a concussive head injury. It was concluded that the studies provided valid scientific evidence to support the safety and efficacy of the ImPACT and ImPACT Pediatric devices.
For more information visit FDA.gov.