Nurea’s PRAEVAorta 2 artificial intelligence (AI)-powered software has received US Food and Drug Administration (FDA) 510(k) clearance, a company press release reveals.
According to Nurea, PRAEVAorta 2 provides vascular physicians with advanced automated measurement tools for aortic diameters on contrasted and non-contrasted computed tomography (CT) scans, supporting diagnosis and patient follow-up in aortic aneurysm management.
Nurea details that its 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. The company notes that early detection and consistent monitoring of abdominal aortic aneurysms (AAAs) are critical to reducing mortality.
Furthermore, Nurea states that the PRAEVAorta suite addresses the economic burden of AAA management. The company claims that the software has the potential to cut the US$1.5 billion annual US 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, chief executive officer and co-founder of Nurea. “FDA clearance validates our vision and allows us to bring PRAEVAorta 2 to US physicians, helping them diagnose and monitor aneurysms more efficiently, reduce costs, and most importantly, save lives.”
