FDA Okays Marketing of First Cognitive Testing Devices for Patients With Head Injury

Deborah Brauser

August 22, 2016

Two medical devices for evaluating symptoms and cognitive function after a head injury have received marketing permission, according to an announcement today from the US Food and Drug Administration (FDA).

The computerized Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) system and ImPACT Pediatric are both manufactured by the ImPACT Applications company.

The first product was created for individuals aged 12 to 59 years who have sustained a head trauma. Using a desktop or laptop computer, licensed clinicians 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, if possible, a patient's own previous scores.

The child-specific ImPACT Pediatric works the same way but is for patients aged 5 to 11 years — and works only on an iPad. It has a game-like design and takes about 10 to 15 minutes to complete.

These are the first medical devices with this indication to receive marketing allowance, noted the FDA in a press release.

"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," Carlos Peña, PhD, director of the FDA's Division of Neurological and Physical Medicine Devices at the Center for Devices and Radiological Health, said in the same release.

In fact, the manufacturer calls these products "concussion management tools" on their website and reports that there are currently 17,000 cases in their normative database.

The FDA used its de novo classification process to review the new testing systems. This type of process is for evaluating first-of-its-kind, low-to-moderate-risk medical devices.

After examining more than 250 peer-reviewed articles submitted by ImPACT Applications, the FDA found that there was "valid scientific evidence to support the safety and effectiveness" of these products.

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