ImPACT Neurocognitive Test Obtains FDA Approval

Impact logoAugust 22, 2016 –  The Food and Drug Administration (FDA) has been expanding the type and scope of medical related items that fall under its supervision. Several years ago they indicated that neuropsychological tests, including the well established and scientifically validated ImPACT Test (The Immediate Post-Concussion Assessment and Cognitive Test), would also be eligible for FDA certification.  This week, following an FDA review process, they announced that both the original ImPACT along with a recently developed ImPACT Pediatric test have been approved for marketing intended to assess cognitive function following a possible concussion.

ImPACT and ImPACT Pediatric are now the first and only neurocognitive tests that are FDA approved.   As noted by the FDA,  “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.”

ImPACT is the most widely used computerized neurocognitive test to help evaluate and manage concussions intended for patients ages 12-59. With the release of ImPACT Pediatric the age limit has been lowered to include ages 5 to 11.  This important addition now allows a larger group of youth to be tested both at baseline and if a concussion were to occur.

The ImPACT test is the most widely used neuropsychological test in the world for the evaluation of concussion.  There are over 250 peer-reviewed articles using ImPACT, of which half were independently conducted clinical research studies.  As part of this recent approval process the FDA concluded that these studies provide valid scientific evidence to support the safety and effectiveness of the ImPACT and ImPACT Pediatric devices. Developed in the early 1990s by Drs. Mark Lovell and Joseph Maroon, ImPACT is a 20-minute test that has become a standard tool used in comprehensive clinical management of concussions for athletes and others. ImPACT Applications, Inc. was co-founded by Mark Lovell, PhD, Joseph Maroon, MD, and Michael (Micky) Collins, PhD. in 2002.

To see the full FDA Announcement CLICK HERE

To see ImPACT Press Release on the New Pediatric ImPACT CLICK HERE

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