The Food and Drug Administration (FDA) announced this 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 their large database of “normal” patients or to a pre-injury baseline test taken by the patient. As the FDA points out in their press release, it 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 its de novo classification process for low to moderate risk devices, devices like ImPACT can be evaluated through a more risk-based approach. We’ve asked the FDA for some more details on the evaluation of ImPACT through this pathway (in particular what class designation is assigned after review) and will update if we get a response.
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, their review of ImPACT offers some insights into where they intend to focus their attention. In this case, it was a computerized concussion screening test for patients used with the supervision of a clinician.
Source: FDA Press Release