Imaging Artificial Intelligence (AI) provider Qure.ai announced its first FDA 510(k) clearance for its head CT scan product qER. The FDA’s decision covers four critical abnormalities identified by Qure.ai’s emergency room product. Now the AI tool can be used to triage radiology scans with intracranial bleeds, mass effect, midline shift and cranial fractures. Two of these capabilities – cranial fractures and midline shift – are exclusive to Qure.ai’s product. This means that the newly cleared qER suite will be able to triage nearly all critical abnormalities visible on routine head CT scans. The qER suite plugs directly into the radiology workflow and prioritizes critical cases on the worklist. This triage drastically reduces the time taken to open critical scans, so those with time-sensitive abnormalities get to be read and reported faster, leading to better patient outcomes.
