ImPACT Applications Launches First Pediatric Medical Device for Concussion Management

 ImPACT Applications announced ImPACT Pedatric, its newest innovation in the field of concussion management. The first and only FDA-approved concussion-specific tool designed for individuals ages 5-11, ImPACT Pediatric provides health care professionals with objective measures of neurocognitive functioning for evaluation and management of concussion in younger children.

ImPACT Pediatric is an iPad-based computerized test that is individually administered, engaging for children, and easy to use in a clinical setting. It addresses a gap that has existed in the medical device community for years — a lack of normed and validated computerized neurocognitive assessment tools for efficiently and effectively measuring neurocognitive function in this age group. Created by ImPACT Applications, the developer of the FDA-approved ImPACT computerized neurocognitive concussion assessment and management tool, ImPACT Pediatric offers pediatric patients the same advantages seen by more than 10 million ImPACT test takers.

“ImPACT Pediatric is a huge step forward for the industry and specifically for pediatric patients who are at-risk of concussion-related injuries,” said Michael Wahlster, chief executive officer of ImPACT Applications. “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.”

According to a study by researchers from the University of Washington and Seattle Children’s Research Institute together with colleagues at the University of Colorado, nearly 2 million children may suffer sports-related concussions each year. As more children below the age of 12 participate in recreational physical activity, often at the recommendation of a health care provider, baseline testing of this demographic population is increasingly essential to overall concussion management protocol.

“ImPACT Pediatric is quick, efficient, and interesting for children to complete on the tablet,” said neuropsychologist Thomas G. Burns, Psy.D, ABPP. “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.”

Like ImPACT, the company’s neurocognitive test for ages 12-59, ImPACT Pediatric has been granted FDA approval as a 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 approval signifies ImPACT Pediatric 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.”