FDA clears AI-powered software for real-time TAVR guidance

Michael Walter | July 16, 2025 | Cardiovascular Business | TAVR

Caranx Medical, a French medtech company, has received U.S. Food and Drug Administration (FDA) clearance for TAVIPILOT Soft, its new artificial intelligence (AI) offering that provides real-time guidance during transcatheter aortic valve replacement (TAVR) procedures.

According to Caranx Medical, TAVIPILOT Soft represents the first FDA-cleared software of its kind. It was designed to help more cardiologists, including those with less experience, perform TAVR and deliver strong patient outcomes.

Caranx Medical is focused on using AI, robotics and other advanced technologies to help expand patient access to life-saving procedures. One of its largest ongoing projects is an autonomous TAVIPILOT robot that will be able to interact with TAVIPILOT Soft and help heart teams perform TAVR. While the TAVIPILOT robot is still being developed, this FDA-cleared software should hit the U.S. market in the months ahead. It was built to be compatible with all modern imaging systems and TAVR valves.

Caranx Medical is backed by Truffle Capital, an established venture capital firm out of Europe.

“This clearance confirms the potential of real-time guidance in TAVI/TAVR procedures to enhance precision and improve patient outcomes,” Jorgen Hansen, Caranx Medical CEO, said in a statement. “We are excited to now move forward with early commercialization by end 2025 and to provide interventional teams with a solution that can support safe and predictable valve deployment.”

“Allowing a broader number of cardiologists and interventional cardiology centers to perform complex procedures, such as TAVR, 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” added Philippe Pouletty, MD, founder of Caranx Medical and CEO of Truffle Capital.