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# Caranx Medical PMA for TAVIpilot AI Software
- URL: https://www.fdaweb.com/caranx-medical-pma-for-tavipilot-ai-software/
- Published: 2025-01-24T12:00:00.000Z
- Updated: 2026-09-14T14:51:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158544

Caranx Medical has submitted a PMA for its TAVIpilot AI Software for real-time intra-operative guidance of transcatheter heart valve implantation. The software is designed to assist surgeons in their positioning of a prosthetic heart valve, according to the company. Preoperative CT-scan images are used to plan the procedure, which is performed through “augmented reality,” it says. “However, during the procedure, they rely only on fluoroscopy, which shows the anatomy indirectly (requiring contrast injection) and transiently.” The software also tracks real-time anatomical and instrument landmarks.