Tuesday, August 23, 2016

FDA Approves Devices for Assessing Cognitive Function After Brain Injury

Two devices for assessing cognitive function immediately following a suspected brain injury or concussion were approved for marketing by the Food and Drug Administration (FDA) yesterday.

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, according to the FDA. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.

“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, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health, in a statement announcing the approval.

ImPACT software runs on a desktop or laptop and is intended for use with those aged 12 to 59, while the ImPACT Pediatric runs on an iPad and is designed for children aged 5 to 11. 

ImPACT and ImPACT Pediatric are not intended to diagnose concussions or determine appropriate treatments. Instead, they are 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 results are compared with an age-matched control database or to a patient’s pre-injury baseline scores if available.

Only licensed health care professionals should perform the test analysis and interpret the results.

The FDA reviewed ImPACT through its de novo classification process, a regulatory pathway for novel, low- to-moderate-risk medical devices that are first of a kind and for which there are special and general controls to provide a reasonable assurance of safety and effectiveness of the devices. The assessment tools are manufactured by ImPACT Applications in Pittsburgh, Pennsylvania.

For related information, see the Psychiatric News article "Computer-Based Tool Can Offer Rapid Screening After TBI."

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