FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury (FDA news release):
“The U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. 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…
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.
Traumatic brain injuries account for more than 2 million emergency room visits in the United States each year, according to the U.S. Centers for Disease Control and Prevention, and contribute to the deaths of more than 50,000 Americans…
The manufacturer submitted over 250 peer-reviewed articles, of which half were independently conducted clinical research studies…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.”
To learn more:
- FDA workshop: Neurodiagnostic Devices Intended to Assess Cognitive Function (PDF – 356KB)
- FDA consumer Update: Can a Dietary Supplement Treat a Concussion? No!
- Trend: Software-based assessments of memory & cognition to detect concussions after head trauma
- Infographic on the Digital Brain Health Market 2012–2020