FDA Clears CT-Based AI Software for Assessment of Aortic Aneurysms
Facilitating timely detection and follow-up management of patients with aortic aneurysms, the PRAEVAorta2 software reportedly enables automated measurement of aortic diameters on computed tomography (CT) scans.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the AI-enabled PRAEVAorta®2 software, which may enhance detection as well as follow-up of aortic aneurysms on contrast-enhanced and non-contrast computed tomography (CT) scans.1
Noting that approximately 20 percent of patients with abdominal aneurysms are undiagnosed, Nurea, the developer of the software, said PRAEVAorta2 provides automated measurements of aortic diameters based on AI-powered analysis of CT scans.
The newly FDA-cleared PRAEVAorta2 software provides automated measurements of aortic diameters based on AI-powered analysis of CT scans, according to Nurea, the developer of the PRAEVAorta2 software. (Image courtesy of Nurea.)
In a 2024 study, researchers found that the PRAEVAorta2 software offered over an 89 percent sensitivity and over a 91 percent specificity for detecting postoperative endoleaks in patients who underwent endovascular aortic repair (EVAR).2
“FDA clearance validates our vision and allows us to bring PRAEVAorta2 to U.S. physicians, helping them diagnose and monitor aneurysms more efficiently, reduce costs, and most importantly, save lives,” added Florian Bernard, the CEO and co-founder of Nurea.
References
- Nurea. Nurea receives FDA clearance for PRAEVAorta®2, bringing advanced aortic aneurysm management to the U.S. market. BusinessWire. Available at: https://www.businesswire.com/news/home/20251014000524/en/Nurea-Receives-FDA-Clearance-for-PRAEVAorta2-Bringing-Advanced-Aortic-Aneurysm-Management-to-the-U.S.-Market . Published October 14, 2025. Accessed October 15, 2025.
2. Coatsaliou Q, Lareyre F, Raffort J, et al. Use of artificial intelligence with deep learning approaches for the follow-up of infrarenal endovascular aortic repair. J Endovasc Ther. 2024 May 9:15266028241252097. doi: 10.1177/15266028241252097. Online ahead of print.
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