FDA Approves First Cognitive Testing Devices For Evaluating Symptoms Of Head Injury

The Food and Drug Administration approved two new cognitive testing devices namely the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric. Medical professionals can now assess effectively the signs and symptoms of patients with head injuries.

Both the testing devices will examine the cognitive skills of the patients such as word memory, reaction time and word recognition. The ImPACT is recommended for patients aged 12 to 59. Meanwhile, the ImPACT Pediatric is for patients aged 5 to 11, according to Fox News.

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 explained that these devices provide a useful new tool to aid in the assessing of patients experiencing possible signs of the concussion. On the other hand, the clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game.

The Food and Drug Administration examined the ImPACT device over and done with its de novo classification process, in which special controls can be developed. It also provides assurances of safety and effectiveness of the devices. The ImPACT device is developed by ImPACT Applications, which is situated in Pittsburgh, Pennsylvania. It is operated on a desktop or laptop computer. On the other hand, the ImPACT Pediatric is a game-like tool that can be applied on an iPad.

The FDA approved the programs for marketing after the submission of more than 250 peer-reviewed articles of the ImPact Applications company. Half of these undergone clinical research studies.

According to the U.S. Centers for Disease Control and Prevention, there are over 2 million visits in an emergency room for traumatic brain injuries in the United States each year. These account for over 50,000 deaths in America each year. They also reported a number of children aged 14 years old and below approximately 214,883 were brought to emergency rooms due to head injuries from 2001 to 2013.