ViTAA Medical Secures FDA 510(k) Clearance for AiORTA™ Plan — Marking the First Step in Its Hyper-Precise Aortic Care Platform

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA™ Plan — Marking the First Step in Its Hyper-Precise Aortic Care Platform

MONTREAL--(BUSINESS WIRE)--Nov 12, 2025-

FDA clears ViTAA Medical’s AI aortic surgery planning tool

ViTAA Medical’s aortic surgery planning tool has gained clearance from the US Food and Drug Administration (FDA), representing the first milestone in the company’s aim to bring a full spectrum aortic care platform to market.The post FDA clears ViTAA Medical’s AI aortic surgery planning tool appeared first on Medical Device Network.

ViTAA Medical’s AiORTA Plan Cleared by FDA

November 12, 2025—ViTAA Medical Solutions Inc. announced that the FDA has granted 510(k) clearance for the company’s AiORTA Plan. According to the company, AiORTA Plan is a fully automated, hyperprecise aortic surgery planning solution that generates a complete aortic plan in minutes to support physicians in preparing aortic interventions. AiORTA Plan is built to automate key preoperative measurements and streamline aortic case prep, providing c…