FDA clears AI solution for identifying large vessel occlusions on CTA
A newly cleared artificial intelligence solution could help providers catch signs of large vessel occlusions in the brain before they lead to more problematic issues, such as ischemic stroke.
Digital healthcare solutions vendor Qure.ai announced the U.S. Food and Drug Administration’s clearance of qER-CTA on Monday. The company says this latest approval further emphasizes its commitment to improving patient outcomes, as the algorithm joins an extensive suite of other AI imaging solutions.
“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,” Jim Mercadante, chief commercial officer at Qure.ai, said in the announcement. “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 new solution can be integrated into computed tomography angiography to help identify large vessel occlusions on imaging. Specifically, it reviews the internal carotid artery and M1 segment of the middle cerebral artery in adults ages 22 and older. If an abnormal finding is identified, qER-CTA sends out an immediate alert, expediting both triage and necessary interventions.
“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,” added Ajith Thomas, MD, chairman with 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."
This latest clearance marks Qure.ai’s 19th from the U.S. FDA. What’s more, the company has over 65 CE certified indications; its solutions are deployed in over 105 countries across nearly 5,000 sites. It also has earned the badge of a TIME100 Most Influential Company 2025.
Learn more about the new algorithm here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.