Jefferson Comprehensive Concussion Center Offers FDA-Cleared ImPACT Pediatric® to the Public
Jefferson Comprehensive Concussion Center (JCCC), a collaboration between Jefferson, Rothman Institute, and Wills Eye Hospital, is one of the first in the Philadelphia region to offer ImPACT Pediatric for baseline and post-injury testing of children five to 11 years of age as part of a comprehensive concussion management protocol. ImPACT Pediatric is the first and only FDA-cleared medical device for pediatric concussion management.
“We are excited to bring our pediatric patients the same tests we have been using with our adult population since the center’s opening in 2013,” says Linda Mazzoli, Director, JCCC. “We are fortunate to have had the opportunity to deliver ImPACT Pediatric baseline testing to the community over the past 18 months through our research partnership with ImPACT Applications, and we have seen its benefits. With full access to this program, and a test standardized for ages five to 11, we can now expand post-injury testing to patients in this age bracket even if they do not have a baseline test. Comprehensive testing is now accessible for nearly all patients at the Center, post-injury or as part of a well child exam.”
ImPACT Pediatric was granted FDA approval last month 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. The company has also received FDA clearance for ImPACT®, a neurocognitive test for ages 12-59. More than 12 million ImPACT tests have been taken worldwide since 2006.
“The Jefferson Comprehensive Concussion Center and its clinical staff have been instrumental in helping us collect data to meet FDA guidelines for clearance. We look forward to expanding our partnership to include a new level of clinical accessibility in the Philadelphia region,” says Mike Wahlster, Chief Executive Officer of ImPACT Applications.
Jefferson Comprehensive Concussion Center offers baseline ImPACT and ImPACT Pediatric testing as well as baseline balance and vision testing at its home office in The Philadelphia Navy Yard. Team baseline testing is available at all Rothman Institute locations.
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