Digital healthcare company Qure.ai announced its latest 510(k) clearance from the U.S. Food and Drug Administration (FDA). This brings its total to 19 FDA clearances.

The newly cleared qER CTA solution analyzes CT angiography (CTA) scans for suspected large vessel occlusions (LVOs) in the brain, which if untreated can cause an ischemic stroke. The solution can review internal carotid artery (MCA) in adults 22 years and older to enable faster triage and specialist notification in emergency care settings.

This FDA nod grows Qure.ai’s FDA-cleared portfolio in neurocritical findings and early cancer care. It builds on a suite of AI solutions for neurocritical conditions in acute care, including triage of intracranial hemorrhages and other critical brain emergencies.

“This FDA clearance is another proof point of how Qure.ai is setting the standard for clinically validated AI that U.S. clinicians can trust to improve patient outcomes,” said Jim Mercadante, chief commercial officer at Qure.ai. “By combining our strengths in acute neurocritical care with advances in early lung cancer detection, we are showing how AI can be seamlessly integrated into clinical workflows to support healthcare professionals in both time-sensitive emergencies and long-term disease management.”

Dr. Ajith Thomas, chairman, department of neurosurgery at Cooper University Healthcare said FDA clearances for AI algorithms like this one are an encouraging step toward deeper AI adoption in clinical practice.

“The qER-CTA algorithm’s ability to triage Large Vessel Occlusions will complement existing AI tools for critical CT findings,” said Dr. Thomas. “This integration promises to fundamentally change traditional workflows, significantly reducing time to treatment in emergency scenarios and strengthening clinical decision-making. If left unidentified, LVOs can rapidly cause ischemic strokes, leading to devastating disability and mortality without timely intervention. AI’s capacity to flag potential occlusions, support rapid triage, and notify specialists sooner has the meaningful potential to dramatically improve patient outcomes.”