FDA Clears First Device Specifically Designed to Assess Function After ConcussionPosted: September 15, 2016
The US Food and Drug Administration (FDA) has given its first-ever clearance for marketing of devices designed to help clinicians assess cognitive function immediately after a suspected brain injury or concussion.
Called Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric, the tool was approved under a new FDA category titled “Computerized Cognitive Assessment Aid for Concussion.” The test battery is already used by more than 7,400 high schools, 1,000 colleges and universities, and 900 clinical centers as a way to test cognitive skills such as word memory, reaction time, and word recognition. ImPACT is designed for use on individuals aged 12 to 59, and operates on a desktop or laptop computer; ImPACT Pediatric is intended for children aged 5 to 11, and is run on an iPad.
While not intended as the sole tool for making a diagnosis or return-to-play decision, the ImPACT device can provide additional evaluative information though comparisons with age-matched databases or patient baseline scores, according to an FDA news release. Pittsburgh, Pennsylvania-based ImPACT Applications submitted more than 250 peer-reviewed articles—half of which were independent clinical research studies—supporting the safety and reliability of the devices.
Prior to the ImPACT approval, the FDA had cleared only devices that help determine the need for imaging after a head injury.