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 TAVIPILOT Soft is a major achievement for the Caranx team. This clearance confirms the potential of real-time guidance in TAVI [transcatheter aortic valve implantation] procedures to enhance precision and improve patient outcomes. We are excited to now move forward with early commercialisation by end 2025 and to provide interventional teams with a solution that can support safe and predictable valve deployment,” says Jorgen Hansen, chief executive officer of Caranx.
“At Caranx Medical, our vision extends to developing our proprietary artificial intelligence platform, currently from more than 5,000 patients with annotated multimodality images of CT [computed tomography], fluoroscopy, echo, data, etc. used to feed our AI algorithms and to revolutionise other cardiovascular indications, such as mitral and tricuspid valve replacements, reshaping the landscape of interventional medicine,” adds CEO of Caranx, Jorgen Hansen.
“Allowing a broader number of cardiologists and interventional cardiology centres 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 revolutionise medicine,” says Philippe Pouletty, founder of Caranx and chief executive officer 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.”
TAVIPILOT Soft is an AI-driven intra-operative software which tracks real-time anatomical and instrument landmarks. It enables precise and accurate heart valve positioning and delivery, Caranx says in a press release. TAVIPILOT Soft is compatible with all cardiac imaging systems and will be compatible with all TAVI heart valves on the market.
