FDA approves devices to test patient’s cognitive skills post head injury

23 August 2016 (Last Updated August 23rd, 2016 18:30)

The US Food and Drug Administration (FDA) has approved two new devices to evaluate a patient's cognitive function following the diagnosis of a suspected brain injury or concussion.

The US Food and Drug Administration (FDA) has approved two new devices to evaluate a patient's cognitive function following the diagnosis of a suspected brain injury or concussion.

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the two devices which have been designed to detect any sign and symptom of a head injury.

The devices are intended to test the patient's cognitive skills such as word memory, reaction time and word recognition which can be affected by head injury.

"The devices are intended to test the patient's cognitive skills such as word memory, reaction time and word recognition which can be affected by head injury."

The ImPACT software operates on a desktop or laptop and is applicable for patients aged between 12 to 59.

The ImPACT Pediatric operates on an iPad and is applicable for children aged between 5 to 11.

The results given by the devices are compared with an age-matched control database or to a patient's pre-injury baseline scores, depending on availability.

FDA Center for Devices and Radiological Health neurological and physical medicine devices division director Carlos Peña said: "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."

The ImPACT device was reviewed through its de novo classification process which is a regulatory way with special controls for low- to-moderate-risk medical devices to evaluate their safety and efficacy.

The device is developed by ImPACT Applications, located in Pittsburgh, Pennsylvania.