An AI tool designed to plan aortic surgery has received US approval.
ViTAA’s FDA approval for its AiORTA tool marks the first step in its comprehensive aortic care platform.
ViTAA Medical Solutions Inc announced the move, giving the green light for its fully automated, hyper-precise aortic surgery planning solution.
The US Food and Drug Administration (FDA) granted 510(k) clearance for AiORTA Plan – a key milestone in the evolution of ViTAA’s broader AiORTA platform built to support physicians across the full continuum of aortic care.
Additional innovations – AiORTA Maps and AiORTA Watch – are currently in multicentre clinical studies, and are progressing rapidly toward future clinical release.
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, and precise diameter and angulation measurements.
It also offers instant volumetric modelling to deliver highly accurate, reproducible results with unprecedented speed and ease of use in the vascular field.
Dr Mitchel Benovoy, CEO of ViTAA Medical, said: ‘This FDA clearance is a foundational milestone for ViTAA. AiORTA Plan brings hyper-precision, efficiency, and extreme speed to the frontline 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.’
Dr Randy Moore, vascular surgeon and CMO at ViTAA Medical, added: ‘Regulatory clearance of AiORTA Plan validates our approach of combining automation with precision medicine. 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studies for AiORTA Maps and AiORTA Watch, we’re focused on delivering solutions that help physicians see beyond outdated size guidelines and gain insights into vessel behaviour that can inform decision-making throughout the patient journey.’
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 US over three decades ago, emphasised the historic importance of this milestone.
He said: ‘This is an important advance. AiORTA Plan can streamline how physicians prepare for complex aortic procedures. As the broader AiORTA platform matures with Maps and Watch in clinical evaluation, it has the potential to transform individualised care by providing critical insight.’
