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

FDA clearance marks a pivotal milestone in ViTAA’s broader AiORTA™ suite, designed to support physicians across the full continuum of aortic care

ViTAA Medical Solutions Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for AiORTA™ Plan, the company’s fully automated, hyper-precise aortic surgery planning solution.

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This clearance represents a key milestone in the evolution of ViTAA’s broader AiORTA™ platform, built to support physicians across the full continuum of aortic care. ViTAA’s additional innovations—AiORTA™ Maps and AiORTA™ Watch—are currently in multicenter clinical studies, progressing rapidly toward future clinical release.

A Leap Forward in Aortic Surgery Planning

Built to automate key preoperative measurements and streamline aortic case prep, AiORTA™ Plan generates a complete aortic plan in minutes. The zero-footprint, web-based system performs automated aneurysm segmentation, centerline extraction, precise diameter and angulation measurements, and instant volumetric modeling to provide highly accurate, reproducible results at speeds and ease of use never before achieved in the vascular field.

“This FDA clearance is a foundational milestone for ViTAA,” said Dr. Mitchel Benovoy, Chief Executive Officer of ViTAA Medical. “AiORTA™ Plan brings hyper-precision, efficiency, and extreme speed to the front line of the aortic workflow. It’s the first step in our platform strategy: from pre-operative planning with AiORTA™ Plan to critical vessel-integrity insights and outcome predictions with AiORTA™ Maps, and long-term post-operative endoleak surveillance and risk stratification with AiORTA™ Watch—both currently in clinical studies. Our vision is end-to-end, patient-specific vascular care at every stage of the disease.”

Validating the Future of Precision Vascular Medicine

“Regulatory clearance of AiORTA™ Plan validates our approach of combining automation with precision medicine,” said Dr. Randy Moore, Vascular Surgeon and Chief Medical Officer at ViTAA Medical. “As we continue our international clinical studies for AiORTA™ Maps and AiORTA™ Watch, we’re focused on delivering solutions that help physicians see beyond outdated size guidelines and gain insights into vessel behavior that can inform decision-making throughout the patient journey.”

Internationally renowned vascular surgeon Dr. Frank J. Veith, Chair of the VEITHsymposium and pioneer who, together with his colleagues, performed the first abdominal aortic endovascular repair (EVAR) in the United States over three decades ago, emphasized the historic importance of this milestone:

“This is an important advance. 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.”

About AiORTA™ Plan

AiORTA™ Plan, with FDA 510(k) clearance (K250337), provides cloud-based, automated pre-operative case planning, including centerline generation, precise diameter metrics, angulation measurements, and instant volumetric analysis to support physicians in preparing aortic interventions. The solution is designed to reduce tedious manual work, improve planning consistency, and integrate seamlessly into existing clinical workflows.

About ViTAA Medical Inc.

ViTAA is advancing vascular AI, imaging, and analytics to transform aortic care throughout the continuum of vascular disease management. The company’s AiORTA™ platform spans planning (AiORTA™ Plan), patient-specific vessel strength analysis (AiORTA™ Maps, currently in clinical studies), and longitudinal monitoring (AiORTA™ Watch, presently in clinical studies).

Meet ViTAA at VEITHsymposium

ViTAA Medical will showcase the AiORTA™ platform at the VEITHsymposium in New York City, November 18–22, 2025. The company will be exhibiting at Booth #500 on the 3rd Floor Pavilion, near the entrance to the Grand Ballroom.

Forward-Looking Statements

This press release may contain forward-looking statements, including statements regarding regulatory pathways and anticipated product performance and benefits. Actual results may differ materially due to risks and uncertainties. ViTAA undertakes no obligation to update forward-looking statements.

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