Impact, the computerized neurocognitive concussion management tool, said it became 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 Impace 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 the company looks forward to continuing to enhance the knowledge base.
Impact Applications works with more than 7,400 high schools, 1,000 colleges and universities, 900 clinical centers, 475 credentialed Impact Consultants, 200 professional teams and select military units to assist in the management of concussion. Since 2006, Impact has served nearly 8 million individual test takers.
