The US FDA has approved the marketing of two devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. Both ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing) and a new test, Pediatric ImPACT, have been granted “do novo” clearance.
ImPACT is the first and only device to receive FDA clearance for concussion assessment.
ImPACT software runs on a desktop or laptop and is intended for those ages 12 to 59, while the ImPACT Pediatric runs on an iPad and is designed for children ages 5 to 11. The device is manufactured by ImPACT Applications.
Dr. Micky Collins, Director of the UPMC Sports Medicine Concussion Program, credits the hard work and support of his colleagues and staff throughout the rigorous approval process. Over 250 peer reviewed manuscripts and extensive accompanying data were submitted to support the application. The FDA approval process took over a year to complete.
Congratulations, Dr. Collins and the UPMC Sports Medicine Concussion Program!