Nurea Gains FDA Clearance for AI Tool Designed to Improve Aortic Aneurysm Diagnosis and Management
French medtech firm Nurea has received clearance from the U.S. Food and Drug Administration (FDA) for its PRAEVAorta 2 software, an advanced AI-powered solution designed to assist physicians in diagnosing and managing aortic aneurysms. This regulatory milestone marks an important step in bringing the company’s vascular imaging tools to healthcare providers across the United States.
PRAEVAorta 2 is part of the broader PRAEVAorta Suite, a collection of software products developed to address a critical gap in cardiovascular diagnostics. Nurea estimates that approximately 20% of aortic aneurysms go undetected, putting patients at significant risk of life-threatening complications such as rupture or dissection. The company’s goal is to help physicians catch these conditions earlier, track their progression over time, and make more informed decisions about treatment.
The software uses AI to automate the analysis of contrast-enhanced or non-contrast CT scans. It can generate precise measurements of the aorta in seconds, including aortic diameter and aneurysm volume. Additionally, it distinguishes between the thrombus and lumen—an important capability that allows for deeper insight into disease severity. Because it eliminates the need for manual tracing or annotations, the platform is described as “zero click,” significantly reducing the time and effort required for clinicians to extract meaningful data from imaging exams.
What sets PRAEVAorta 2 apart from many other imaging tools is its longitudinal focus. The system is built to support clinicians throughout a patient’s entire care journey—from the initial detection of an aneurysm to ongoing surveillance years later. This continuous monitoring capability makes it particularly useful in managing chronic vascular conditions that require regular follow-up imaging and consistent measurement comparisons over time.
The software was previously granted CE mark approval, enabling its use in the European Union. Now with FDA clearance, Nurea is prepared to expand its reach into U.S. clinical settings, where physicians are increasingly turning to AI for help with imaging interpretation and patient management. The company believes PRAEVAorta 2 can improve workflow efficiency, enhance diagnostic accuracy, and support earlier intervention—all while reducing unnecessary costs and improving patient outcomes.
“This milestone is the result of years of research, development, and collaboration,” said Florian Bernard, CEO and co-founder of Nurea. “FDA clearance validates our vision and allows us to bring PRAEVAorta 2 to U.S. physicians, helping them diagnose and monitor aneurysms more efficiently, reduce costs and most importantly, save lives.”
As AI continues to reshape the landscape of medical imaging, Nurea’s PRAEVAorta platform demonstrates how targeted applications of the technology can streamline complex diagnostic processes, improve long-term patient care, and ultimately reduce the burden of vascular disease on healthcare systems worldwide.