The US Food and Drug Administration (FDA) has granted marketing permission for the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric – the first medical devices intended to evaluate cognitive function after a suspected concussion.
The ImPACT software, available on a computer or tablet, is meant to be part of a full medical evaluation and is not intended to diagnose concussion on its own.
“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 neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in a statement.
The ImPACT and ImPACT Pediatric evaluate cognitive skills that may be affected by brain injury, including word memory, reaction time, and word recognition, and then compare results with an age-matched control database or the person’s pre-injury baseline scores, whichever is available. The ImPACT is intended for people aged 12 to 59 years, while the pediatric version is intended for those aged 5 to 11 years. The pediatric version, which runs on an iPad, is designed with a game-like interface and takes approximately 10 to 15 minutes to complete. Notably, the test and its results are should be administered and interpreted by a health care professional.
The FDA approved the devices through its de novo classification process, in which more than 250 peer-reviewed articles – half of which were independently conducted clinical research – were reviewed for evidence supporting the safety and efficacy of the devices.
The ImPACT devices are available for purchase online by health care clinics and institutions and academic institutions.
FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury [press release]. FDA Newsroom; August 22, 2016.