Everyone and their dog seems to be offering some sort of panacea to manage concussions and diagnose or treat head injuries.
But in clearing two first-of-its kind products on Monday, the Food and Drug Administration was very careful in highlighting what they do not do: diagnose concussions.
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The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices that are computerized cognitive tests that assess an injured person’s cognitive skills such as word memory, reaction time and word recognition. All these could well be affected after a head injury.
What the agency seeks to do instead is to add novel weapons to the physician’s arsenal in properly evaluating a patient who has been hurt.
“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,” said Carlos Peña, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, in a statement.
The two tests are made by ImPACT Applications, which touts on its website that it is the “most widely used and most scientifically validated computerized concussion management tool available” and declares that the test has been administered 10 million times to more 7.5 million people since 2006. The tests can be administered first as a baseline test and the after injury a follow-up test can detect how scores are different from the original. Or the test can be administered only after injury and compare with a normative score as part of a healthcare provider’s assessment of the injury.
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FDA noted that ImPACT Applications submitted more than 250 peer-reviewed articles, of which half were independently conducted clinical research studies. Based on that, FDA concluded that the devices were safe and effective, the dual pillars by which the agency judges an application even if they be de novo – low risk products that have no existing, predicate devices on the market.
The test for 12-59 year-olds runs on a desktop or laptop while the pediatric version runs on an iPad and can be administered to kids as young as 5. However, only licensed health care professionals should perform the test analysis and interpret the results.
While the ImPACT test now bears the weight of an FDA stamp of approval, there are other players in the marketplace that are attempting to tackle concussions using the pathway of lab-developed tests. One such company is Quanterix that has the backing of the National Football League. It has developed the Simoa platform, which uses single molecule measurements to access previously undetectable proteins.
