PRAEVAorta®2
Overview
PRAEVAorta®2 is a Class IIb medical device (CE, 2797) and FDA-cleared software developed by Nurea, a French medtech company. It is designed as a decision-making support tool for the diagnosis and follow-up of vascular diseases, particularly aortic aneurysms. The software provides automated segmentation and geometric analysis of vessels from contrasted and non-contrasted DICOM CT images.
Utilizing complex numerical simulation tools and image processing algorithms, PRAEVAorta®2 offers a “0 click” workflow, presenting direct views on multiple clinical parameters. This automation significantly reduces the time required for diagnosis and follow-up, with studies showing it can be 95% faster than manual segmentation while maintaining precision. It standardizes measurements, thereby eliminating variability induced by manual operation and improving reproducibility for more accurate disease evolution analysis.
PRAEVAorta®2 seamlessly integrates into existing clinical workflows and everyday tools such as PACS, workstations, and imaging software. It can differentiate the lumen from the thrombus, allowing for the extraction of additional criteria not easily accessible to physicians. The software supports the entire patient journey, from incidental detection of aneurysms to automated surgery planning and yearly post-surgery follow-up.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Use Cases
- Diagnosis of vascular diseases, including aortic aneurysms
- Follow-up and monitoring of vascular disease progression
- Automated surgery planning for procedures like EVAR / FEVAR
- Aneurysm epidemiology and maximum diameter assessment
- Clinical research in cardiovascular imaging
- Creation of patient registries for surgical eligibility and surveillance
What Physicians Need to Know
PRAEVAortau00ae2 offers a 'zero-click' workflow for automated aortic measurements, significantly reducing the time and effort required for analysis and improving diagnostic efficiency. Its ability to standardize measurements enhances reproducibility and allows for more accurate analysis of disease progression over time. The tool supports the entire patient journey for aortic aneurysm management, from incidental detection to automated surgery planning and yearly follow-up, ultimately aiming to improve patient outcomes and reduce costs.
PRAEVAortau00ae2 is designed for seamless integration into existing clinical workflows and common imaging infrastructure, including PACS, workstations, and other imaging software. It also has established partnerships, such as integration with the deepcOS platform, to assist radiologists and surgeons in diagnostics and surgical planning.
Details
| Category | Cardiology AI, Radiology & Imaging AI |
| Pricing | Contact for pricing |
| Deployment | Software, integrated into existing clinical workflows and systems (PACS, workstations, imaging software) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Nurea has received U.S. Food and Drug Administration (FDA) 510(k) clearance (K243859) for its PRAEVAorta®2 software on August 29, 2025. The software is intended to automatically calculate maximum diameters of anatomical zones from DICOM CT images containing blood vessels, using a non-adaptative machine learning algorithm. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiothoracic Surgery, Radiology, Vascular Surgery |
What the Web Says
PRAEVAortau00ae2 is an AI-powered software designed to assist physicians in diagnosing and managing aortic aneurysms by automating the analysis of CT scans. It aims to improve diagnostic accuracy, enhance workflow efficiency, and support earlier intervention and continuous monitoring of chronic vascular conditions. The software has received FDA clearance in the U.S. and CE mark approval in Europe, indicating its readiness for broader clinical adoption.
Overall: PositiveStrengths
- Automated and precise measurement of aortic diameters and aneurysm volumes from CT scans, reducing manual effort and time.
- Ability to differentiate between thrombus and lumen, providing deeper insights into disease severity.
- Supports longitudinal patient care, from initial detection to long-term surveillance, which is crucial for chronic vascular conditions.
- Demonstrated excellent correlation and accuracy in measuring maximum aortic diameters compared to manual methods.
- Potential to reduce healthcare costs associated with aneurysm screening and management.
- Improved diagnostic accuracy and efficiency, potentially leading to earlier intervention and better patient outcomes.
Limitations
- A reported 10% segmentation error rate in some studies, necessitating critical review of generated reports by experienced observers.
- Segmentation errors can occur due to failure in detecting vessel segments or mis-detecting the outer border of the aneurysm.
- Most common risk factors for segmentation failure include internal iliac artery occlusions and overlapping aneurysms.
- Evidence is currently limited by small, retrospective, and heterogeneous studies, highlighting the need for large-scale prospective validation.
- Lack of comprehensive reviews from platforms like Reddit, G2, or Capterra, indicating limited public or tech reviewer opinions available.
Based on reviews from: Nurea: AI solution for vascular diseases, Artificial intelligence in aortic CT angiography: current applications and future perspectives, External Validation of Fully-Automated Infrarenal Maximum Aortic Aneurysm Diameter Measurements in Computed Tomography Angiography Scans Using Artificial Intelligence (PRAEVAorta 2) - PubMed, Nurea Gains FDA Clearance for AI Tool Designed to Improve Aortic Aneurysm Diagnosis and Management | Applied Radiology, Nurea gets U.S. FDA nod for CT software - AuntMinnie, Accuracy of fully automated iliac artery tortuosity measurements in patients with abdominal aortic aneurysm using deep learning - PMU Research Portal, Nurea Receives FDA Clearance for PRAEVAortau00ae2, Bringing Advanced Aortic Aneurysm Management to the U.S. Market - Business Wire, PRAEVAortau00ae2 - Sectra Amplifier Marketplace, Multicentric Clinical Evaluation of a Computed Tomography based ..., Automatic Detection of Visceral Arterial Aneurysms on Computed ..., Automatic Segmentation of Intraluminal Thrombus in Abdominal Aortic Aneurysms Based on CT Images: A Comprehensive Review of Deep Learning-Based Methods - MDPI, Study Details | NCT05920317 | Comparison of a Full Automatic Software With Standard Methods of Vessels Analysis | ClinicalTrials.gov, GEFu00c4u00df CHIRURGIE - 42. DGG-Jahrestagung 2026, Imaging analysis using Artificial Intelligence to predict outcomes after endovascular aortic aneurysm repair: protocol for a retrospective cohort study | BMJ Open, Christian UHL | Heidelberg University, Heidelberg | Department of Vascular Surgery (Heidelberg) | Research profile - ResearchGate, Automatic CTA analysis for blood vessels and aneurysm features extraction in EVAR planning - PMC, The Operative Role of Artificial Intelligence in Vascular Surgery: A Systematic Review of Literature - ResearchGate, Description: External validation of fully-automated infrarenal ...
Last updated: 2026-07-21
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