On Aug. 22, the U.S. Food and Drug Administration announced that two computerized devices used to assess a patient’s cognitive function following a brain injury have been approved for marketing in Florida and nationwide. In a press release, the agency said the devices are intended to help doctors evaluate the signs and symptoms of concussions and other traumatic brain injuries, or TBIs.
ImPACT and ImPACT Pediatric test a TBI patient’s word memory, word recognition and reaction time, which are cognitive skills that could be negatively affected by a brain injury. The results of the tests are compared to an individual’s pre-injury baseline score or an age-matched control database. The tests are not intended to diagnose head injuries but act as one assessment tool in a comprehensive evaluation process. ImPACT software is designed for patients ages 12 to 59, and ImPACT Pediatric is intended for children ages 5 to 11. To gain FDA approval, the manufacturer submitted more than 250 peer-reviewed articles demonstrating the validity and safety of the devices.
According to the Centers for Disease Control and Prevention, more than 2 million Americans are treated for TBIs in emergency rooms each year. Most of these TBIs are mild concussions, but over 50,000 people die from head injuries in the U.S. annually.
Individuals who suffer a traumatic brain injury could face short-term and long-term health issues, including memory problems, mood changes and even degenerative brain diseases. People who have been injured in this manner due to the negligence of another party may benefit by discussing their legal options with an attorney. It may be advisable to file a personal injury lawsuit seeking compensation for medical expenses, lost wages and pain and suffering.
Source: FDA, “FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury,” Aug. 22, 2016