FDA OKs Caranx’s AI Software for Real-Time Guidance During TAVI

Caranx Medical has received U.S. Food and Drug Administration (FDA) clearance for the world’s first artificial intelligence (AI) software for real-time, intra-operative guidance of transcatheter aortic valve implantation (TAVI).

Tavipilot Soft is an AI-driven intra-operative software that tracks real-time anatomical and instrument landmarks to provide precise, accurate heart valve positioning and delivery. The software aims to be a revolution for transcatheter aortic valve replacement (TAVR), which is currently restricted to the most experienced, TAVI-trained cardiologists.

Tavipilot Soft was submitted to the FDA in January 2025.

The software is compatible with all cardiac imaging systems and will be compatible with all TAVI heart valves on the market. The company plans to introduce Tavipilot Soft by the end of 2025.

“Obtaining FDA clearance for TAVIPILOT Soft is a major achievement for the Caranx team,” said Caranx CEO Jorgen Hansen. “This clearance confirms the potential of real-time guidance in TAVI/TAVR procedures to enhance precision and improve patient outcomes. 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.”

While 300,000 TAVI procedures are performed annually in the US and EU, 1,700,000 patients need a TAVI procedure. According to Frost & Sullivan, annual TAVI sales are $8 billion, and the market exhibits double-digit annual growth.

“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,” says Philippe Pouletty, MD, founder of Caranx and CEO of Truffle Capital. “We are assessing how to make Caranx future even more promising and ambitious, with potential collaborations with other cardiovascular-focused companies, in the context of an ambitious project named CarvOlympics.”