French MedTech company Caranx Medical has announced the US Food and Drug Administration (FDA) submission of artificial intelligence (AI)-powered TAVIPILOT Soft.
The intuitive software provides real-time intra-operative guidance for Transcatheter Aortic Valve Implantation (TAVI).
According to Caranx Medical, TAVIPILOT Soft is the world’s first AI-powered tool for transcatheter heart valve implantation. It is designed for use with TAVI-PILOT, a robotic solution for autonomous valve positioning and delivery.
In April last year, the medical device company announced the first robotic-assisted transcatheter heart valve implantation in an animal.
The FDA submission supports Caranx’s strategy for the planned market launch of TAVIPILOT Soft by the end of this year.
TAVIPILOT Soft tracks real-time anatomical and instrument landmarks during surgery.
It ensures precise and accurate heart valve positioning and delivery.
Designed to advance aortic valve replacement, TAVIPILOT Soft makes this procedure accessible beyond just cardiologists and specialised centres.
The company said that the intra-operative software is compatible with all major cardiac imaging systems and TAVI heart valves existing in the market.
Caranx CEO Jorgen Hansen said: “The team at Caranx has achieved an important milestone in the submission to the Food and Drug Administration, FDA.
“This extremely promising step paves the way to early commercialisation of the TAVIPILOT Soft by end 2025.
“I am very excited about the real-time guidance of TAVI/TAVR, a key to accurate and precise positioning of the heart valve as well as the promotion of potentially more predictable and controlled valve deployment.”
Caranx Medical is backed by Truffle Capital, a firm engaged in European biotech and MedTech investment.
The company plans to serve globally the AI and robotic-assisted transcatheter heart valve implantation sector.
Truffle Capital CEO and Caranx founder Philippe Pouletty said: “Allowing a broader number of cardiologists, surgeons and interventional cardiology centres to perform complex procedures, such as TAVI, 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”
