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announced last week that it had approved the ImPACT software and medical app, designed to help clinicians test cognitive skills after a head injury.
Concussions and other head injuries, particularly related to sports, have garnered a lot of attention in recent years. We've covered a number of medical apps designed to help clinicians assess for concussions at the point of care. NYU Langone also recently launched the Concussion Tracker ResearchKit app to better characterize symptom evaluation after a concussion, which is critical to designing medical apps aimed at diagnosing concussions.
Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) has two versions. The first is designed for patients between 12 to 59 years old and runs on a laptop. The other, ImPACT Pediatric, is for kids younger than 12 years old and runs on an iPad. It's designed to perform a clinician-guided test of cognitive skills like word memory, reaction time and word recognition to aid in assessment of head injuries. Tests take about 25 minutes and results can be compared to an age-matched cohort from the company's large database of "normal" patients or to pre-injury baseline test taken by the patient. As the FDA points out in its press release, ImPACT is not designed to diagnose a concussion or recommend treatment.
ImPACT was approved through a special regulatory pathway for some novel medical devices, which would typically automatically be Class III devices and therefore garner the most stringent oversight. Through the FDA's de novo classification process for low- to moderate-risk devices, devices like ImPACT can be evaluated through a more risk-based approach. According to the FDA, ImPACT was classified as Class II medical device and evaluated accordingly. That fact has important implications for other similar medical apps and software that may follow, using ImPACT as a predicate device.
While recent guidance from the FDA on general health apps showed us the areas of digital health of which the FDA is going to steer clear, the agency's review of ImPACT offers some insights into where it intends to focus its attention.
This post appeared on iMedicalApps.com.