FDA Issues First-Ever Clearance for a Concussion-Specific Device

ImPACT, the most widely-used and most scientifically-validated computerized neurocognitive concussion management tool available, is the first medical device of its kind to receive U.S. Food and Drug Administration (FDA) de novo clearance. FDA clearance has been granted under Computerized Cognitive Assessment Aid for Concussion, a new category for a device that uses an individual’s score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. FDA de novo clearance signifies ImPACT has met the FDA’s premarket requirements to demonstrate accuracy, validity, and reliability for concussion management and specifically states that ImPACT will “aid in the assessment and management of concussion.”
 
“ImPACT’s FDA clearance is a huge step forward for the industry, for athletes and others who are at-risk of concussion-related injuries, as well as for licensed, trained medical professionals everywhere,” said Michael Wahlster, CEO of ImPACT Applications. “ImPACT Applications has a proven commitment to science, research, and innovation. That is why a global network of hospitals, clinics, youth sports organizations, and professional athletes utilize and trust ImPACT.”
 
ImPACT is the only concussion-specific tool with more than 14 years of independent evaluation and scientific validation. In addition, over 250 peer-reviewed articles, of which half were independently conducted clinical research studies, have built ImPACT’s foundation of trust and value. By achieving FDA clearance in a new category, ImPACT Applications continues to fulfill its role as a pioneer in concussion management by providing customers the safest and most effective concussion management tools on the market.
 
FDA clearance comes at a time when concussion awareness is growing rapidly. The FDA’s clearance is evidence that ImPACT is an effective tool that adds another level of accountability to the return-to-activity decisions of health care professionals who use ImPACT as part of their concussion management protocol.
 
FDA de novo clearance is one of several steps ImPACT Applications is taking to advance the science of concussion management, and ImPACT Applications looks forward to continuing to enhance the knowledge base.