FDA Approves Marketing of New Computerized, Cognitive Tests

Friday the U.S. Food and Drug Administration permitted the marketing of two new devices that will help assess a patient’s cognitive function immediately following a suspected traumatic brain injury.

“The Immediate Post- Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury,” an article on Sharp Brains website reads. “ImPACT software runs on a desktop or laptop and is intended for those ages 12 to 59, while the ImPACT Pediatric runs on an iPad and is designed for children ages 5 to 11. Only licensed health care professionals should perform the test analysis and interpret the results.”

Read More: Traumatic Brain Injury Attorney in Wisconsin

According to the Center for Disease Control , each year traumatic brain injuries contribute to a substantial number of deaths and cases of permanent disability. In 2010, 2.5 million TBIs occurred either as an isolated injury or along with other injuries.

A TBI is caused by a bump, blow or jolt to the head or a penetrating head injury that disrupts the normal function of the brain. Not all blows or jolts to the head result in a TBI. The severity of a TBI may range from mild, a brief change in mental status or consciousness to severe, an extended period of unconsciousness or amnesia after the injury.

“The manufacturer submitted over 250 peer-reviewed articles, of which half were independently conducted clinical research studies, according to the article. “The FDA concluded that these studies provide valid scientific evidence to support the safety and effectiveness of the ImPACT and ImPACT Pediatric devices. The FDA reviewed the ImPACT device through its de novo classification process, a regulatory pathway for novel, low- to-moderate-risk medical devices that are first-of-a-kind, for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices.”