The FDA awarded ImPACT Applications de novo clearance for two new devices to evaluate a patient’s cognitive function following a suspected brain injury or concussion. While the devices are not meant to diagnose concussion or determine its treatment, they will be included in the medical evaluation for head injury.
The devices, dubbed the ImPACT (Immediate Post-Concussion Assessment and Cognitive Test) and ImPACT Pediatric, are computerized tests that assess cognitive skills that a head injury could affect, such as word memory, reaction time and word recognition, according to an FDA statement. Scores would be compared against an age-matched control database or to pre-injury baseline scores if available for the patient.
The ImPACT software is cleared for patients aged 12 to 59, and runs on a desktop or laptop computer. The pediatric version is cleared for those aged 5 to 11 and runs on a tablet.
The de novo review pathway is for novel, low- to moderate-risk devices that are first-of-its-kind. A new category was made under which the ImPACT devices and similar products will be regulated: Computerized Cognitive Assessment Aid for 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," said ImPACT Applications CEO Michael Wahlster, in an ImPACT statement.
The FDA go-ahead comes at a point where concussion awareness is rising. In March, the agency convened a public workshop to discuss potential biomarkers and their development and use in diagnosing traumatic brain injury.
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