FDA Clears Qure.ai’s New AI Solution for Early Detection of Large Vessel Occlusions

A newly approved artificial intelligence tool aims to help healthcare providers detect large vessel occlusions (LVOs) in the brain before they lead to severe complications such as ischemic stroke.

Digital health company Qure.ai announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its latest product, qER-CTA. The company stated that this new approval strengthens its mission to enhance patient outcomes, adding to its growing portfolio of AI-powered medical imaging tools.

“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.”

The qER-CTA solution integrates with computed tomography angiography (CTA) to assist in identifying large vessel occlusions. It specifically analyzes the internal carotid artery and the M1 segment of the middle cerebral artery in adults aged 22 and older. When the algorithm detects an abnormality, it automatically sends an alert to clinicians, accelerating both patient triage and the initiation of critical treatment.

“The qER-CTA algorithm's ability to triage large vessel occlusions will complement existing AI tools for critical CT findings. This integration promises to fundamentally change traditional workflows, significantly reducing time to treatment in emergency scenarios and strengthening clinical decision-making,” said Ajith Thomas, MD, chairman of the department of neurosurgery at Cooper University Healthcare. “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.”

The FDA’s clearance of qER-CTA marks Qure.ai’s 19th regulatory approval in the United States. Beyond that, the company holds more than 65 CE-certified indications across its product line, with deployments spanning over 105 countries and nearly 5,000 clinical sites worldwide.

Qure.ai’s growing global footprint and recognition underscore its rising influence in the medical AI sector. The company was recently named one of TIME100’s Most Influential Companies of 2025, reflecting its expanding role in developing solutions that bridge artificial intelligence and clinical medicine to advance diagnostic accuracy and patient care.