Qure.ai, a TIME100 most influential company and global leader in digital healthcare, today announced its latest (510) K clearance from the US Food and Drug Administration (FDA). This milestone represents ongoing momentum in Qure.ai’s USA growth strategy and highlights its ongoing ability to deliver rigorously validated solutions that integrate seamlessly into hospital and clinical workflows to enhance patient outcomes.
The newly cleared solution, qER-CTA, is designed to assist clinicians by analyzing CT angiography (CTA) scans for suspected large vessel occlusions (LVOs) in the brain, which if untreated could cause an ischemic stroke. The solution can review internal carotid artery (ICA) and M1 segment of the middle cerebral artery (MCA) in adults (≥22 years), enabling faster triage and specialist notification in emergency care scenarios.
This clearance expands the Qure.ai FDA cleared portfolio in neurocritical findings and early cancer detection, reflecting the company’s ability to deliver clinically proven tools across multiple domains of care. It builds on a suite of AI solutions for neurocritical conditions in acute care, including the triage of intracranial haemorrhages and other critical brain emergencies. Qure.ai also continues to drive progress in its FDA cleared lung cancer solutions underscoring its commitment to improving both time-critical and long-term outcomes.
“This FDA clearance is another proof point of how Qure.ai is setting the standard for clinically validated AI that US 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 states, “FDA clearances for AI algorithms like this represent 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. 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.”
Over the past several years, Qure.ai has built an unmatched portfolio of global approvals, with 19 FDA cleared findings, over 65 CE certified indications, and other national validations across its solutions. Deployed in over 105 countries across 4800+ sites, Qure.ai is touching more than 34 million lives. This milestone further strengthens its position as the most regulatory-approved AI provider in healthcare imaging and reinforces its commitment to building clinically validated tools that empower healthcare professionals in time-critical decision making.