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October 22, 2025
Nurea PraevAorta 2 Software Cleared by FDA for Aortic Aneurysm Management
October 22, 2025—Nurea announced that its PraevAorta 2 software has received FDA 510(k) clearance for the United States market.
According to Nurea, a developer of artificial intelligence–powered medical imaging, PraevAorta 2 provides automated measurement tools for aortic diameters on contrasted and noncontrasted CT scans, supporting diagnosis and patient follow-up in aortic aneurysm management.
The PraevAorta suite, which integrates the newly cleared PraevAorta 2 software, is designed to create registries that enable fast identification of patients who are eligible for surgery and those requiring continued surveillance, thereby ensuring that no patient is left without follow-up after intervention, stated Nurea.
Additionally, the company advised that the PraevAorta suite addresses the economic burden of aortic aneurysm management by enabling incidental detection on both contrasted and noncontrasted CT scans while integrating into existing clinical workflows.
The newly FDA-cleared PraevAorta 2 is a class IIb medical device that has also received European CE Mark approval, noted the company.
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