Mumbai-based startup 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.

“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.

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."