PRAEVAorta®2

Evidence summary

FDA technical assessment used 159 independent adult CT cases from the United States, France, and Canada, with four vascular surgeons providing manual measurement reference. Maximum orthogonal aortic-diameter mean absolute error was 2.04 mm (95% CI 1.75-2.34); 96.9% of values were within 5 mm. The latter is measurement agreement, not disease-detection accuracy.

FDA source Exact FDA submission Checked 2026-09-05

• Source

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify security and privacy controls: FDA functional data-security testing and general vendor language do not establish a current scoped attestation, hosting region, retention policy, or access-control configuration.
• Verify training: Training of reference readers in the FDA study is not a customer onboarding commitment. Current user training and support terms remain unverified.
• Verify pricing and total cost: The reviewed official product page offers a demo without scoped pricing. Licensing, processing volume, client/integration costs, support, and cloud/on-premises terms require quotation; procurement research is incomplete.
• Verify reimbursement and coding relevance: No applicable payer policy was reviewed. No named-product coverage or payment conclusion is made.
• Verify local validation and lifecycle monitoring: Local acceptance, output correction, update control, and incident escalation require vendor and site documentation.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

All stored metadata screened. PMID 40480487 abstract supports a contextual PRAEVAorta2 study, without exact-build linkage. PMID 41321026 concerns carotid-lesion segmentation; exact aortic-product applicability not established and no results promoted. Live registry content identifies NCT05287828 and NCT05920317 as Nurea/PRAEVAorta-family studies; no posted results or exact K243859 build linkage were established, so neither is promoted as exact-submission clinical performance. The current discovery snapshot contains 2 PubMed and 2 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, fda decision material, vendor product page, literature index, peer reviewed literature, trial registry, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) K243859: PRAEVAorta 2 U.S. Food and Drug Administration · 2026-09-05
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• PRAEVAorta®2 model card (K243859) American College of Radiology · 2026-09-01
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• PRAEVAorta 2 decision support software for vascular diseases Nurea · 2026-09-05
• Validation Study Comparing Artificial Intelligence for Fully Automatic Aortic Aneurysms Segmentation and Diameter Measurements on Contrast and Noncontrast Enhanced Computed Tomography Annals of Vascular Surgery; abstract via PubMed · 2026-09-05