Regulatory Focus™ > News Articles > FDA Clears Test for Measuring Post-Concussion Cognitive Function

FDA Clears Test for Measuring Post-Concussion Cognitive Function

Posted 23 August 2016 | By Michael Mezher 

FDA Clears Test for Measuring Post-Concussion Cognitive Function

The US Food and Drug Administration (FDA) on Monday announced it cleared the first computer-based tests for measuring cognitive function after a suspected concussion in both adults and children.

Concussions have been a growing concern in recent years, as a growing body of evidence suggests the potential for concussions to have long-term health implications, especially in sports such as football and ice hockey where players are at a high risk for head injuries in both practice and competition.

According to the US Centers for Disease Control and Prevention (CDC), traumatic brain injuries were linked to approximately 2.5 million emergency room visits, hospitalizations or deaths in 2010, and are occurring at an increasing rate in children under 19.

"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 [and] are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of head injury," FDA says.

However, the agency says the tests are not meant to diagnose concussions themselves, or determine how to treat patients.

"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. The results are compared to an age-matched control database or to a patient's pre-injury baseline scores, if available."

The tests were developed by Pittsburgh-based company ImPACT Applications and were reviewed by FDA through its de novo classification process, as no similar tests had been previously cleared by the agency.

According to FDA, ImPACT Applications submitted more than 250 peer-reviewed articles analyzing the ImPACT tests "including the devices' validity, reliability and ability to detect evidence of cognitive dysfunction that might be associated with a concussive head injury."


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