FDA Approves Cognitive-Testing Tool The U.S. Food and Drug Administration recently approved marketing of two new software programs to assess post-concussion cognitive function in children and in adults. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first FDA-permitted medical devices to be marketed to assess cognitive function following a ... News in Brief
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News in Brief  |   November 01, 2016
FDA Approves Cognitive-Testing Tool
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Regulatory, Legislative & Advocacy / Attention, Memory & Executive Functions / Traumatic Brain Injury / News in Brief
News in Brief   |   November 01, 2016
FDA Approves Cognitive-Testing Tool
The ASHA Leader, November 2016, Vol. 21, 9. doi:10.1044/leader.NIB5.21112016.9
The ASHA Leader, November 2016, Vol. 21, 9. doi:10.1044/leader.NIB5.21112016.9
The U.S. Food and Drug Administration recently approved marketing of two new software programs to assess post-concussion cognitive function in children and in adults.
The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first FDA-permitted medical devices to be marketed to assess cognitive function following a possible concussion.
The devices are not intended to diagnose concussions or determine treatments, but to test cognitive skills such as word memory, reaction time and word recognition. Results are compared to an age-matched control database or to the patient’s pre-injury baseline scores, if available.
The adult-version software, intended for 12- to 59-year-olds, runs on a desktop or laptop. The pediatric version, designed for children 5–11, runs on an iPad. Based on research studies submitted by the manufacturer—Pittsburgh-based ImPACT Applications—the FDA concluded that the software programs are safe and effective.
1 Comment
November 11, 2016
Kathryn Hardin
Not helpful for SLPs
The FDA approval of ImPACT testing will likely imply support of a measurement tool that has clear problems with reliability, validity, and diagnostic utility (Alsalaheen, Stockdale, Pechumer, & Broglio, 2016). This is particularly striking for SLPs who already struggle to find adequate, functional assessments for our clients post-concussion. As a field, we must continue to pursue high-quality tools that address the broad set of needs impacting communication and cognition post mild traumatic brain injury.
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FROM THIS ISSUE
November 2016
Volume 21, Issue 11