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 cloud-based, automated preoperative case planning, including centerline generation, precise diameter metrics, angulation measurements, and instant volumetric analysis, noted ViTAA Medical.

The company advised that AiORTA Plan is part of ViTAA Medical’s broader AiORTA platform, which is intended to support physicians across the continuum of aortic care. Its additional innovations (AiORTA Maps and AiORTA Watch) are currently in multicenter clinical studies, advised the company.

ViTAA advised it will showcase the AiORTA platform at the 2025 VEITHsymposium held November 18-22 in New York, New York.

Frank J. Veith, MD, Chair of the VEITHsymposium, addressed the significance of the clearance in the company’s press release.

“This is an important advance,” commented Dr. Veith. “AiORTA Plan can streamline how physicians prepare for complex aortic procedures, and as the broader AiORTA platform matures with Maps and Watch in clinical evaluation, it has the potential to transform individualized care by providing critical insight.”