Caranx Medical, a French medical technology company focused on advancing transcatheter aortic valve implantation (TAVI), has announced the first clinical use of its TAVIPILOT Soft software, marking a world-first in real-time, AI-driven intra-operative guidance for TAVI procedures. The milestone was achieved at Clinique Pasteur in Toulouse, France, between October 20 and 22, 2025, as part of the SAITO-1A first-in-human study. The trial involved 10 patients with severe aortic stenosis, all treated via the transfemoral approach using an Edwards Sapien 3 valve. TAVIPILOT Soft, cleared by the FDA for commercial use in July 2025, demonstrated 100% technical reliability across all procedures. The software autonomously identified key anatomical landmarks and accurately assessed valve implantation depth in real time. Comparisons between the software’s predicted valve position and the final position chosen by the interventional team showed excellent precision in every case. No intra-procedural complications were reported, and the clinical team expressed high satisfaction with the system’s performance. The results confirm the feasibility, safety, and technical robustness of the AI-powered software during live TAVI procedures. The success of the study paves the way for early commercialization, with Caranx planning to launch TAVIPILOT Soft in the United States by the end of 2025. Eric Sejor, Caranx’s Chief Medical Officer, said the milestone represents a major step forward in improving procedural precision and patient outcomes. “This first clinical use validates the potential of real-time AI guidance in TAVI, making the procedure safer, more predictable, and accessible to a broader range of medical teams,” he said. TAVI, introduced about two decades ago, remains a complex procedure with a steep learning curve, limiting its availability to only the most experienced cardiologists. With an estimated 1.7 million patients in need annually and over 300,000 procedures performed each year in the U.S. and EU, the market for TAVI is growing rapidly, valued at $8 billion and expanding at double-digit rates, according to Frost and Sullivan. Caranx believes its technology can significantly increase the number of patients who can benefit from the procedure. Philippe Pouletty, MD, founder of Caranx and CEO of Truffle Capital, emphasized the company’s mission: “Our goal is to democratize access to life-saving TAVI procedures by empowering more cardiologists and centers with AI and robotics, ultimately saving more lives and transforming interventional cardiology.” TAVIPILOT Soft is an easy-to-use, AI-driven software that tracks real-time anatomical and instrument positions during surgery. It is compatible with all major cardiac imaging systems and all leading TAVI heart valves on the market. The system has shown strong resilience to patient motion, including cardiac and respiratory movement, as well as C-arm and table movement. Pierre Berthet-Rayne, Caranx’s Chief Technology Officer, described the software as a “GPS for the heart,” providing real-time navigation that enhances safety and accuracy. The company is also building a proprietary AI platform with over 5,000 annotated multimodal images from CT, fluoroscopy, and echocardiography to support future applications in mitral and tricuspid valve interventions. Jorgen Hansen, CEO of Caranx, said the company is committed to expanding its AI platform to address a range of cardiovascular conditions, aiming to revolutionize interventional medicine. Backed by a team of top medical and technology experts and supported by Truffle Capital, Caranx Medical is positioned to become a global leader in AI and robotic-assisted heart valve implantation.