For perspective on the growing concern that the medical community and the sporting world has for concussions, consider the stricter protocols that sporting bodies at all levels have adopted for head injuries. Athletes suspected of a head injury are removed from play and they must pass a battery of tests before they can return. Medical device startup ImPACT Applications aims to help medical professionals determine if a patient has suffered a head injury. The Pittsburgh, Penn.-based company has developed technology that can help doctor’s assess whether a patient has such an injury. The Food and Drug Administration recently granted marketing approval for ImPACT Applications’ products, clearing the way for their use by medical professionals.
ImPACT Applications’ technology is called Immediate Post-Concussion Assessment and Cognitive Testing, or ImPACT. The company received FDA approval on two devices, ImPACT for use on adults and ImPACT Pediatric for children. The company’s product is software; ImPACT can run on a desktop or laptop and is intended for use on patients between the ages of 12 to 59, the FDA said. ImPACT Pediatric, which runs on an iPad, is designed for children 5 to 11 years of age. The software runs the patient through a series of tests that evaluate reaction time, word recognition, word memory, and non-verbal problem solving, explains mHealthIntelligence.
The ability to run head injury tests on a laptop or a tablet allows assessments to be done close to the field of play. But the FDA cautions that only medical professionals are permitted to perform these tests and interpret the test results. The ImPACT Applications devices are also not approved for diagnosing concussions. The FDA explains that the devices are a new tool that helps clinicians assess head injury. Carlos Pena, director of the division of neurological and physical medicine at the FDA, said that doctors should not rely on these devices alone to assess head injuries.
The FDA’s approval of ImPACT Applications products through the de novo classification process follows the submission of more than 250 peer-reviewed articles assessing the technology. Half of those articles were independently conducted clinical research studies, which provided valid scientific evidence supporting both the safety and the efficacy of the products, the FDA said.
While the head injury products from ImPACT Applications are new, the company’s technology is actually decades old. The company originally developed its head-injury assessment technology in the 1990s for use on computers, explains MobiHealthNews. But ImPACT Applications says on its website that its technology is already used by more than 1,000 colleges and universities and 200 professional sports teams. The new FDA marketing approval now helps ImPACT Applications make a stronger case for a product that can help clinicians make better diagnostic assessments.
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