FDA News

ImPACT computerized tests for postconcussion assessments gain FDA marketing OK

The FDA recently approved the marketing of a pair of medical devices, including one intended for pediatric patients, designed to assess cognitive functioning after head injuries or suspected concussions.

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric, both marketed by ImPACT Applications, are intended to test cognitive skills of patients who could be affected by concussion, including word memory, reaction time and word recognition.

“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,” Carlos Peña, PhD, MS, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in an FDA press release.

ImPACT software runs on a desktop or laptop; ImPACT Pediatric runs on an iPad. The former is designed for patients aged 12 to 59 years, while the latter is intended for children aged 5 to 11 years. Primary care physicians and licensed health care professionals only should administrate the results of the tests that are compared with an age-matched control database or a patient’s baseline scores before injury.

The release said the manufacturer submitted more than 250 peer-reviewed articles that included research publications that included the devices’ validity, reliability and ability to detect dysfunction in cognitive skills that might be linked with head injuries. The FDA concluded that the research analysis supported both devices as largely safe and effective.

The FDA recently approved the marketing of a pair of medical devices, including one intended for pediatric patients, designed to assess cognitive functioning after head injuries or suspected concussions.

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric, both marketed by ImPACT Applications, are intended to test cognitive skills of patients who could be affected by concussion, including word memory, reaction time and word recognition.

“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,” Carlos Peña, PhD, MS, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in an FDA press release.

ImPACT software runs on a desktop or laptop; ImPACT Pediatric runs on an iPad. The former is designed for patients aged 12 to 59 years, while the latter is intended for children aged 5 to 11 years. Primary care physicians and licensed health care professionals only should administrate the results of the tests that are compared with an age-matched control database or a patient’s baseline scores before injury.

The release said the manufacturer submitted more than 250 peer-reviewed articles that included research publications that included the devices’ validity, reliability and ability to detect dysfunction in cognitive skills that might be linked with head injuries. The FDA concluded that the research analysis supported both devices as largely safe and effective.