NICE, France– Caranx Medical, a French medtech company developing robotic and AI solutions for cardiovascular procedures, announced it has received U.S. FDA clearance for its groundbreaking product, TAVIPILOT Soft—the world’s first artificial intelligence software designed for real-time intra-operative guidance during transcatheter aortic valve implantation (TAVI).
The clearance marks a major milestone for Caranx as it moves toward U.S. market launch by the end of 2025. TAVIPILOT Soft uses AI to assist cardiologists with real-time tracking of anatomical and instrument landmarks, offering improved precision and safety during heart valve placement. The system is compatible with all current cardiac imaging platforms and TAVI valves, aiming to make a complex and life-saving procedure more accessible.
“Obtaining FDA clearance for TAVIPILOT Soft is a major achievement for the Caranx team,” said Jorgen Hansen, CEO of Caranx Medical. “This clearance confirms the potential of real-time guidance in TAVI procedures to enhance precision and improve patient outcomes. We are excited to now move forward with early commercialization and to provide interventional teams with a solution that can support safe and predictable valve deployment.”
TAVI procedures, introduced around 20 years ago, are still among the most technically challenging in cardiology due to the need for precise valve placement. While roughly 300,000 TAVI procedures are performed annually across the U.S. and Europe, an estimated 1.7 million patients could benefit from the procedure—highlighting the need for scalable solutions like Caranx’s AI platform.
Caranx’s technology is based on data from over 5,000 patients, using multimodal imaging—including CT, fluoroscopy, and echocardiography—to train its AI algorithms. The company sees the TAVIPILOT platform as the first step in transforming not just aortic valve procedures, but also expanding into mitral and tricuspid valve replacements and other cardiovascular interventions.
“Allowing a broader number of cardiologists and interventional cardiology centers to perform complex procedures, such as TAVI, with the Caranx AI-driven software and autonomous robot is at the heart of our mission of entrepreneurs and business builders to save lives and revolutionize medicine,” said Philippe Pouletty, M.D., founder of Caranx and CEO of Truffle Capital.
TAVIPILOT Soft is designed to simplify and democratize a procedure typically limited to highly trained specialists. By enhancing precision and reducing the learning curve, the software could make advanced heart valve therapy more widely available across healthcare systems.
The announcement comes as the global TAVI market continues its rapid growth, currently valued at $8 billion with strong double-digit annual increases, according to Frost & Sullivan.
