The FDA has granted de novo clearance to two concussion assessment software products from ImPACT Applications. The Pittsburgh-based company developed its original software in the 90s for computers, though the clearance also includes ImPACT Pediatric, a newer version of the tests for children that runs on an iPad.
"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," Michael Wahlster, CEO of ImPACT Applications, said in a statement. "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."
The FDA was careful in the announcement of the classification to make clear that the devices, which test skills like word memory and reaction time and compare them to a baseline, are not cleared to diagnose concussions.
“These devices provide a useful new tool to aid in the evaluation of patients experiencing possible signs of a concussion, but clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game,” Carlos Peña, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in a statement.
ImPACT submitted an immense amount of research -- over 250 peer-reviewed articles, of which half were independently conducted clinical research studies -- in order to secure its status as the first concussion assessment software to be FDA-cleared.
ImPACT is an increasingly mobile-focused company: In addition to its assessment products, ImPACT Applications makes two other "passport" apps that allow providers and patients to store and access test result data.