Nurea Receives FDA Clearance for PRAEVAorta®2, Bringing Advanced Aortic Aneurysm Management to the U.S. Market

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BORDEAUX, France--(BUSINESS WIRE)--Oct 14, 2025--

Nurea, a pioneer in AI-powered medical imaging, today announced that its PRAEVAorta®2 software has received FDA 510(k) clearance, enabling entry into the U.S. market. PRAEVAorta®2 provides vascular physicians with the most advanced automated measurement tools for aortic diameters on contrasted and non-contrasted CT scans, supporting diagnosis and patient follow-up in aortic aneurysm management.

More than a measurement tool, PRAEVAorta®Suite integrating PRAEVAorta®2 helps save time in the patient care pathway by creating registries enabling fast identification of patients eligible for surgery and those requiring continued surveillance – ensuring that no patient is left without follow-up after intervention.

Aortic aneurysms, often referred to as “the silent killer,” affect millions of patients worldwide and cause tens of thousands of deaths annually in the U.S. alone. They are the 10th leading cause of death for men over 55 in the United States, with an estimated 20% of patients remaining undiagnosed. Early detection and consistent monitoring are critical to reducing mortality.

Beyond clinical outcomes, PRAEVAorta® Suite addresses the economic burden of AAA management: the software has the potential to cut the $1.5 billion annual U.S. screening cost in half by enabling incidental detection on both contrasted and non-contrasted CT scans, while smoothly integrating into existing clinical workflows.

“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.”

PRAEVAorta®2 is a class IIb medical device, CE marked (2797). PRAEVAorta®2 is a FDA approved medical device. Please read the instructions carefully.

This information is intended for U.S. healthcare professionals.

About Nurea

Founded in 2018 and based in Bordeaux, France, Nurea develops AI-powered medical imaging solutions to support clinicians in managing vascular diseases. Its flagship product, PRAEVAorta®2, is a Class IIb CE-marked medical device in Europe and now FDA-cleared in the United States. By combining artificial intelligence with biomedical modeling, Nurea aims to improve patient outcomes and streamline healthcare delivery worldwide.

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INDUSTRY KEYWORD: SOFTWARE RESEARCH PROFESSIONAL SERVICES BIOMETRICS MEDICAL DEVICES TECHNOLOGY ARTIFICIAL INTELLIGENCE HEALTH TECHNOLOGY DATA ANALYTICS SCIENCE FDA HEALTH

SOURCE: Nurea

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PUB: 10/14/2025 06:00 AM/DISC: 10/14/2025 05:59 AM

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