The Food and Drug Administration recently approved two new medical software applications as devices that help physicians assess a patient’s cognitive function following a possible concussion.
According to the FDA, the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first such medical devices permitted for marketing in the U.S. to inform clinical decisions.
Such tools are considered important because it’s difficult to diagnose and treat a concussion or other traumatic brain injuries.
Nonetheless, the regulatory agency is quick to add that ImPACT and ImPACT Pediatric are “not intended to diagnose concussions or determine appropriate treatments” but are instead “meant to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury.”
The ImPACT software runs on a desktop or laptop and is designed for patients ages 12 to 59. The iOS-based ImPACT Pediatric runs on an iPad and is meant for children ages 5 to 11. The FDA warns that “only licensed healthcare professionals should perform the test analysis and interpret the results.” The results of individual tests are compared with an age-matched control database or with a patient’s pre-injury baseline scores, if available.
“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,” said Carlos Peña, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health.
“We are the first to be cleared by the FDA backed by a huge amount of research,” says Mike Wahlster, CEO of ImPACT Applications, which makes the software and maintains what he contends is the industry’s largest database of clinical research studies on concussion management.
The ImPACT products were reviewed by the regulatory agency under its de novo classification process for “novel, low- to moderate-risk medical devices that are first-of-a-kind and for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices,” according to the FDA.
ImPACT Applications, which recently relocated its operations from Pittsburgh to San Diego, submitted more than 250 peer-reviewed articles—of which half were independently conducted clinical research studies—with the FDA, concluding that the studies “provide valid scientific evidence to support the safety and effectiveness of the ImPACT and ImPACT Pediatric devices.”
The software will be made available only to qualified healthcare providers, not on public venues. “We do not sell to the general public,” adds Wahlster.
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