TAVIpilot Soft for AI-Driven Intraoperative Guidance Cleared by FDA

July 18, 2025—Caranx Medical, a France-based medical device company that is developing an autonomous robot for access to transcatheter aortic valve implantation/replacement (TAVI/TAVR, recently announced FDA clearance for the United States commercialization of TAVIpilot Soft. TAVIpilot Soft is an artificial intelligence (AI) software for real-time intraoperative guidance of transcatheter heart valve implantation.

Caranx is planning the United States market introduction of TAVIpilot Soft by the end of 2025.

According to the company, the AI-driven TAVIpilot Soft solution is an intraoperative software that tracks real-time anatomic and instrument landmarks. It enables precise and accurate heart valve positioning and delivery. TAVIpilot Soft is compatible with all cardiac imaging systems and will be compatible with all TAVR heart valves on the market.

After its first-in-human use in 2025, Caranx expects to gradually commercialize the TAVIpilot robotic solution with autonomous control in all key markets.

The company announced its submission to FDA for TAVIpilot Soft in January 2025.