Caranx Medical Wins FDA Clearance for AI Heart Valve Guidance Software

Caranx Medical wins FDA Clearance for AI heart valve guidance software

Caranx Medical's AI software advances TAVI procedures, enhancing precision and accessibility for heart valve surgeries, improving patient outcomes.

Caranx Medical Announces FDA Clearance of TAVIPILOT Soft: the World's First AI Software for Real-Time Intra-Operative Guidance of Transcatheter Heart Valve Implantation

NICE, France--(BUSINESS WIRE)--Jul 15, 2025-

Caranx Medical’s AI TAVI-TAVR software gains FDA approval

The US Food and Drug Administration (FDA) has cleared Caranx Medical’s TAVIPILOT Soft, an artificial intelligence (AI)-based guide software for use during Transcatheter Aortic Valve Implantation (TAVI) or replacement procedures (TAVR).The post Caranx Medical’s AI TAVI-TAVR software gains FDA approval appeared first on Medical Device Network.

US FDA gives approval to commercialise AI software to guide transcatheter procedures - Cardiovascular News

TAVI Caranx Medical has announced US Food and Drug Administration (FDA) clearance for the commercialisation of its artificial intelligence (AI) software for real-time intra-operative guidance of transcatheter heart valve (THV) implantation. The FDA clearance marks a significant milestone of Caranx’s strategy towards planned market introduction of TAVIPILOT Soft by the end of 2025, the company says in a press release. “Obtaining FDA clearance for…