FDA Approves Head Injury Screening Tests

New computer software to assess the brain’s function after a traumatic head injury have been approved by the U.S. Food and Drug Administration. According to the FDA, traumatic brain injuries account for more than 2 million trips to the emergency room in the United States each year. These injuries contribute to the deaths of some 50,000 people in the U.S. annually.

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test and the ImPACT Pediatric version are intended to be part of the medical evaluation that physicians perform to assess signs and symptoms of a head injury.  The ImPACT system is intended for individuals aged 12 to 59 while ImPACT Pediatric was designed for patients aged 5 to 11.

The devices are not intended to diagnose concussion or to determine whether an injured player should return to a game. They are meant to test cognitive skills such as time and word recognition. The software runs on laptop or desktop computers.

In a recent news release, Carlos Pena, Ph.D., M.S., director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health said “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.”

Manufacturer ImPACT Applications, based in Pittsburgh, submitted more than 250 peer-reviewed articles of the test as part of it application for the FDA’s de novo device approval process, which is geared toward “novel, low-to-moderate-risk medical devices that are first of a kind.”  The company said more than half of those 250 studies were conducted independently by clinical researchers.