FDA Has Cleared the First Computerized Tests used to Assess Cognitive Function

The U.S. Food and Drug Administration just recently announced on Monday August 22nd, 2016 that they have cleared two new computer-based tests that will be used to measure cognitive function after a suspected brain injury or concussion. The “Immediate Post-Concussion Assessment and Cognitive Testing” (ImPACT and ImPACT Pediatric) are the first medical devices to be permitted for marketing that are used for this purpose.

Concussions have been a growing concern due to the fact that traumatic brain injuries account for more than 2 million emergency room visits and more than 50,000 deaths in the United States every year.  These devices will be used as part of the medical evaluation that licenced health care professionals will perform on patients to assess signs and symptoms.  It is important to note that ImPACT devices are not made to diagnose concussions or determine their appropriate treatments.  They are simply made to “test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury.”

These tests were developed by ImPACT Applications, located in Pittsburgh, Pennsylvania.  This manufacturer submitted more than 250 peer-reviewed journal articles where over 50% were independently conducted clinical trials.  The FDA has concluded that these various studies have “provided valid scientific evidence to support the safety and effectiveness of the ImPACT and ImPACT Pediatric Devices.”  With the use of this software it will be possible to analyse and test patients from the ages of 5 all the way to 59 years old.

We hope that this information is helpful to you.  Contact Focal Point Research if you need assistance bringing your medical devices to market.  We are industry leading Medical Device Consultants that you can trust to help guide your company in the right direction.