Caranx Medical has announced that it has made a submission to the US Food and Drug Admnistration (FDA) for its artificial intelligence (AI) software for real-time intra-operative guidance of transcatheter aortic valve implantation (TAVI)—Tavipilot.
The FDA submission marks a significant milestone in the company’s strategy towards planned market introduction of the software by the end of 2025, Caranx Medical says in a press release.
“The team at Caranx has achieved an important milestone in the submission to the 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, a key to accurate and precise positioning of the heart valve as well as the promotion of potentially more predictable and controlled valve deployment,” says CEO of Caranx, Jorgen Hansen
“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,” says Philippe Pouletty, founder of Caranx and CEO of Truffle Capital
“This first release of our Tavipilot software marks an important step toward AI-augmented procedures. Our software is designed to be user-friendly, ensuring that cardiologists and surgeons can integrate it seamlessly into their usual practice. Tavipilot Soft allows clinicians to position a prosthetic valve easily and with high precision, ensuring that more patients could benefit from a high quality of care,” says Caranx co-founder and CTO, Pierre Berthet-Rayne
“Tavipilot Soft is a breakthrough for TAVI procedures, providing millimetric precision using augmented reality. Clinicians use precise preoperative images (computed tomography [CT] scans) for the planning of TAVI. However, during the procedure, they rely only on fluoroscopy, which shows the anatomy indirectly (requiring contrast injections) and transiently. Accurately positioning the valve requires long training and experience. Our Tavipilot Soft identifies key heart anatomical features for precise valve placement and is expected to transform TAVI procedures for patients and clinicians” says Caranx co-founder and CMO, Eric Sejor.
Tavipilot Soft is an AI-driven intra-operative software which tracks real-time anatomical and instrument landmarks. It is compatible with all cardiac imaging systems and will be compatible with principal TAVI heart valves on the market, the company press release adds.
