Qure.ai Nets Second FDA Clearance for Brain CT Scan AI

Qure.ai has announced US FDA 510(k) clearance for its brain CT quantification product qER-Quant. Clinicians in the US can now use this tool to rapidly and precisely assess the severity of injury in patients with conditions like traumatic brain injury, hemorrhagic stroke, and hydrocephalus and to track the progression of pathology over time.

Ajith Thomas MD, Associate Professor of Neurosurgery, Harvard Medical School and Co-Director, Brain Aneurysm Institute, Beth Israel Deaconess Medical Center said, “The use of AI will be transformative in the management of traumatic brain injury by obtaining an expedient and accurate diagnosis. Congratulations to Qure.ai for being at the forefront of this paradigm shift!”

CT scans are the most widely used exam for brain injuries and are used to help diagnose millions of patients that visit the emergency room every year. AI assistance speeds up treatment and transfer decisions, helps monitor patients more closely and reduces the chances of diagnostic errors.

“Qure.ai’s technology makes it possible to systematically measure brain hemorrhages precisely and rapidly in patients with stroke or trauma. Fully automated quantification could soon become the standard of care.” says Dr Johan Wasselius, Interventional Neuroradiologist at the Skåne University Hospital and Lund University, Sweden.

“This FDA clearance adds quantification, outlining and measurement capabilities to Qure.ai’s first clearance for triage and notification of critical brain abnormalities. We are excited about bringing a complete suite of capabilities to clinicians who deal with critical head CT scans,” said Dr. Pooja Rao, co-founder and R&D head, Qure.ai.

“We’ve always built products to solve real customer challenges and qER Quant is another example of the same. We worked on this capability based on customer feedback from radiologists, neurologists, and ER physicians who expressed the need to get automated volume measurements on neuro scans to assess patient progress as well as safe discharge decisions. It helps us offer a more comprehensive suite of AI tools to our US clinical partners,” said Prashant Warier, CEO and co-founder, Qure.ai.

The AI tool is also cleared for marketing in the EU, and is currently used by teleradiology providers, emergency care physicians and radiologists at more than 40 clinical sites.