ViTAA Medical Secures FDA 510(k) Clearance for AiORTA Plan, Launching Its Hyper-Precise Aortic Care Platform

ViTAA Medical has received FDA 510(k) clearance for its AiORTA Plan, marking a key milestone in launching its platform for hyper-precise aortic care13510.

AiORTA Plan is a fully automated, web-based solution that generates a complete aortic plan in minutes, automating preoperative measurements like aneurysm segmentation, centerline extraction, diameter and angulation measurements, and instant volumetric modeling135.

The tool is designed to reduce manual workload, improve planning consistency, and integrate seamlessly into clinical workflows for aortic interventions15.

This clearance represents the first commercial step for ViTAA’s broader AiORTA platform, which also includes AiORTA Maps for vessel-strength analysis and AiORTA Watch for postoperative surveillance—both currently in clinical studies15.

Company leadership highlights that AiORTA Plan advances precision, efficiency, and speed in aortic surgery planning, aiming for end-to-end, patient-specific vascular care throughout all disease stages15.

Regulatory clearance validates ViTAA’s approach of combining automation with precision medicine to help physicians make better clinical decisions beyond traditional size-based guidelines15.

Sources:

1. https://financialpost.com/pmn/business-wire-news-releases-pmn/vitaa-medical-secures-fda-510k-clearance-for-aiorta-plan-marking-the-first-step-in-its-hyper-precise-aortic-care-platform

3. https://evtoday.com/news/vitaa-medicals-aiorta-plan-cleared-by-fda

5. https://vascularspecialistonline.com/vitaa-medical-announces-fda-510k-clearance-for-aortic-planning-platform/

10. https://ground.news/article/vitaa-medical-secures-fda-510k-clearance-for-aiorta-plan-marking-the-first-step-in-its-hyper-precise-aortic-care-platform