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Despite New De Novo Clearance To Assess Brain Injury, ImPACT Concussion Assays Have Been Used For Years

Executive Summary

US FDA granted a de novo clearance for ImPACT Applications's ImPACT and ImPACT pediatric tests to assess a patient's cognitive functions for suspected brain injury on Aug. 22, defining a new class of device, "Computerized Cognitive Assessment Aid For Concussion", but the devices have actually been in widespread use by health care providers on behalf of US parents, sporting teams, and schools since 2006, the company tells Medtech Insight.

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