Source: prnewswire.com | Re-Posted Duerson Foundation 8/25/2016 –
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.”
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“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, Chief Executive Officer 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.”