FDA gives Pa. company all clear for medical device to assess concussion recovery

For the first time, the FDA is giving clearance to a concussion-monitoring medical device.

ImPACT, with offices in Pennsylvania and San Diego, offers a series of computer-based tests that measure cognitive function. The company contracts with medical providers, schools and athletic teams, performing baseline assessment of skills such as word memory and reaction time. That information is then compared with test results after a suspected concussion to help doctors assess a patient’s recovery. (ImPACT is not used to diagnose a concussion.)

Calling the device safe and effective, the FDA announced Monday that ImPACT was cleared for marketing its main product, as well as a version geared at children ages 5 to 11.

“In a way it is validation that all of the research we had been the subject of, or had conducted on our own, backs up the claims we’ve made about the product over the years,” said ImPACT CEO Michael Wahlster.

The ImPACT test has been performed nearly 8 million times on patients and athletes in the U.S. and Canada. It is widely available at medical offices in our region.

The baseline assessments are designed to take about 20-minutes to complete. For patients suspected of suffering a concussion who haven’t been pre-screened, the software compares results with an age- and education-matched control database.

The FDA’s decision comes a year after the company first began the clearance process. Wahlster said concussions and other traumatic brain injuries continue to inspire new innovations in the industry.

“The public awareness has certainly increased exponentially over the last several years … and has certainly brought this issue to the forefront for, particularly, parents,” he said.