The US Food and Drug Administration announces its marketing approval of two medical devices for evaluating a patient’s symptoms and cognitive function after experiencing a traumatic brain injury.
The devices are the computerized Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) system, as well as the ImPACT Pediatric system. Both devices are manufactured by Pittsburgh-based ImPACT Applications Inc, according to Medscape.
The ImPACT system, for patients ages 12 to 59 years old, works with a desktop or laptop computer. Using the system, physicians use specialized software to assess a patient’s cognitive skills, such as working memory, attention span, nonverbal problem solving, and reaction time. The results are then matched to a control-group database or the patient’s previous scores.
The ImPACT Pediatric system, for patients ages 5 to 11, works the same way, but it differs in that it works only on an iPad, it has a game-like design, and it takes about 10 to 15 minutes to complete.
Per the Medscape story, a press release from the FDA notes it gave its approval after examining more than 250 peer-reviewed articles about the devices submitted by ImPACT Applications. In its approval, the FDA found there was “valid scientific evidence to support the safety and effectiveness” of these devices.
However, Carlos Peña, PhD, director of the FDA’s Division of Neurological and Physical Medicine Devices at the Center for Devices and Radiological Health, warns in the release that, “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.”
[Source(s): US Food and Drug Administration, Medscape]
