The U.S. Food and Drug Administration (FDA) granted access for ImPACT to enter the market as a computerized cognitive test to treat patients with a suspected brain injury. The press release was published on Monday, and it sets a milestone for medical devices that assess cognitive functions. ImPACT is the first of its kind in the market.
The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) is a test to be used after a person suffered possible concussion or another head injury that could affect cognitive functions. The FDA approved both ImPACT and ImPACT Pediatric, but it must be clear that neither of the devices is meant to diagnose concussions or determine treatment.
ImPACT was developed as a test to assess cognitive skills such as word memory, reaction time and name recognition as part of the medical evaluation.
Cognitive functions can be affected by head trauma and are essential for understanding in a first glance what could be the cause of the symptoms and if the injury is affecting the brain. ImPACT assess similar parameters that the Glasgow coma scale. A computerized tomography (CT) and other evaluations are needed to proceed with treatment.
Once the patient has finished the test using ImPACT, the results are compared to an age-matched control database and if it is available, to the patient’s baseline scores before the brain injury.
How does ImPACT work and how do we now it is trustworthy?
ImPACT software runs on a desktop or laptop, and it was designed for people between 12 and 59 years old. Through a set of tests ImPACT can assess working memory, attention span, non-verbal problem solving and reaction time to certain activities to determine cognitive dysfunctions. ImPACT Pediatric only works on iPads, but it evaluates the same cognitive skills. The test is designed as a game to catch the child’s attention. It could take about 10 to 15 minutes to complete.
For Dr. Carlos Peña, Ph.D., M.S., director of the division of neurological and physical medicine devices and the FDA’s Center for Devices and Radiological Health, ImPACT is a useful tool to use as part of the medical evaluation. The new tool helps to assess patients that are experiencing possible signs of a concussion. He highlights that ImPACT cannot be used to give a final diagnose on a patient’s health state.
To support ImPACT, the FDA reviewed the device through its Novo classification process. Said method is a regulatory test to determine if novel, low-to-moderate-risk medical devices that are unique in the market will work properly with humans. For first-of-a-kind products, the FDA can use special controls in addition to the general ones with the purpose of assuring that the new device, this case ImPACT, is safe and efficient.
ImPACT manufacturer has submitted over 250 peer-reviewed articles that analyzed the ImPACT and its value regarding reliability and ability to detect cognitive dysfunctions that might be associated with a head trauma.
According to the U.S. Center for Disease Control and Prevention, traumatic brain injuries are the cause of more than 2 million emergency room visits in the United States each year. They are also the cause of 50 thousand deaths. The good news is that a significant percentage of these injuries, such as concussion, are considered to be mild and treatable.
Source: FDA