The Food and Drug Administration granted de novo clearance for ImPACT, a device used to assess cognitive function following possible concussion or brain injury.
The device tests cognitive skills like word memory and reaction time and compares the results to an age-matched control database or a patient's baseline scores, if available. While ImPACT aids in the evaluation of patients exhibiting possible signs of a concussion, it should not be used alone to provide a diagnosis.
ImPACT Applications, the Pittsburg, Pa.-based manufacturer of the device, submitted more than 250 peer-reviewed articles to the FDA that support the device's safety and effectiveness.
The agency reviewed ImPACT through its de novo classification process meant for low- to moderate-risk devices that are the first of their kind and require special regulatory controls.
ImPACT is intended for adults aged 12 to 59. The company also offers ImPACT Pediatric to assess children aged 5 to 11.