Qure.ai, a global provider of imaging AI solutions, has received its first US FDA 510(k) clearance for 'qER,' its head CT scan product. The FDA's approval
paves the way for Qure.ai's AI tool to triage radiology scans detecting intracranial bleeds, mass effect, midline shift, and cranial fractures, with the last two capabilities being exclusive to Qure.ai. This development makes qER capable of triaging almost all critical markers visible on routine head CT scans.
With over 75 million CT scans performed annually in the US, the demand for a comprehensive, high-quality imaging AI tool is apparent. "The sooner doctors have in-depth information, the better for the patient. qER plays a key role in this," said Pooja Rao, Co-founder and R&D head of Qure.ai.
The qER suite integrates directly into the radiology workflow, prioritizing critical cases and reducing the time to access essential scans. It has undergone extensive validation and is actively deployed worldwide at numerous hospitals and teleradiology providers.