FDA clears Impact, U.S.’s 1st concussion management device

The FDA yesterday granted de novo clearance to Impact Applications for its ImPACT computerized neurocognitive concussion management tool, touting it as the 1st of its kind to win clearance from the agency.

The application has been granted clearance as a computerized cognitivie assessment aid for concussion, which is a new device category which uses an individual’s scores on a battery of cognitive tasks to provide an indication of cognitive function in response to 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. 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,” CEO Michael Wahlster said in a prepared statement.

Upon receiving the clearance, the Pittsburgh, Penn.-based company said it had launched ImPact Pediatric, a new concussion-specific tool designed for individuals between ages 5 and 11.

“ImPACT Pediatric is a huge step forward for the industry and specifically for pediatric patients who are at-risk of concussion-related injuries. Unlike older age groups who are often baseline tested before injury, concussion management for young children is mostly reactive. ImPACT Pediatric allows for proactive baseline testing for well-child patients and insight into cognitive changes if an injury occurs. It produces easy to use, secure, and manageable test results with age-referenced normative comparisons,” CEO Wahlster said in a press release.

“ImPACT Pediatric is quick, efficient, and interesting for children to complete on the tablet. It also provides norm-referenced baseline data for ages 5-11. ImPACT Pediatric makes it easier for the clinician to monitor recovery and ultimately to inform return–to-activity decisions,” neuropsychologist Thomas Burns said in prepared remarks.

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