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ViTAA’s AiORTA Plan Receives FDA Clearance

ViTAA’s AiORTA Plan Receives FDA Clearance

ViTAA Medical has secured FDA clearance for AiORTA Plan, the first component of its upcoming full-suite aortic care platform. AiORTA Plan uses AI to automate key preoperative tasks for complex aortic surgeries, including aneurysm segmentation, centreline generation, and volumetric analysis, helping improve accuracy and reduce manual planning.

The platform will later include AiORTA Maps and AiORTA Watch. AiORTA Maps applies AI to CT scans to assess vessel integrity, thrombus burden, and generate a Regional Aortic Weakness (RAW) Score, developed from 15 years of research and over 200 tissue samples. It is currently being studied in a prospective registry and across multiple U.S. research sites.

AiORTA Watch will offer real-time monitoring of aortic health once developed. ViTAA says the suite aims to move clinicians beyond traditional size-based guidelines by providing deeper insights into vessel behaviour, aligning with the growing role of AI in medical imaging and surgical planning.

16-11-2025