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Screening Device For Head Injuries Gets Approval

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Doctors now have a new, technologically-advanced way to determine if a patient has a concussion. The US Food and Drug Administration has approved the use of new computer software designed to assess brain function after a serious head injury.

Called the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), the software will be used by doctors to evaluate signs and symptoms of head injuries that could become concussions, the FDA said in a news release. This includes assessments for cognitive skills such as working memory, nonverbal problem solving, attention span and reaction time. A patient’s results will then be matched to a database or a patient’s previous scores, if they exist. The software can run on either laptops or desktop computers, US News reports.

A similar test for children, ImPACT Pediatric, has likewise been approved, but this version only works on an iPad. The test has a game-like design that takes around 10 to 15 minutes for a child to complete.

Traumatic head injuries account for over 2 million visits to the emergency room in the United States annually, the FDA says. These injuries, in turn, cause some 50,000 deaths yearly.

The ImPACT test for adults is approved for ages 12 to 59, and the pediatric test for kids from 5 to 11 years old. These are the first medical devices of their kind to receive marketing approval, the FDA notes. They underwent the FDA’s de novo classification process, which the agency uses for new, low-to-moderate risk medical apparatuses.

ImPACT Applications, the company behind the software, turned in over 250 peer-reviewed articles to support their product. The company refers to these products as “concussion management tools” on their website and states that there are 17,000 cases in their database, Medscape reports.

After examining the ImPACT submissions, the FDA said there was “valid scientific evidence to support the safety and effectiveness” of the tests.

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