Caranx Medical, a French medical device innovator developing autonomous robotic solutions to democratise access to transcatheter aortic valve implantation (TAVI), has announced US FDA clearance for the commercialisation of Tavipilot Soft — the world’s first AI-powered software for real-time intra-operative guidance in transcatheter heart valve procedures.

This milestone advances Caranx’s strategic roadmap towards launching Tavipilot Soft in the US market by the end of 2025.

“This FDA clearance is a significant achievement for our team,” said Jorgen Hansen, CEO of Caranx Medical. “Real-time guidance technology like Tavipilot Soft has the potential to enhance accuracy, streamline valve deployment, and improve patient outcomes. We are now well positioned to begin early commercialisation efforts later this year.”

TAVI (transcatheter aortic valve implantation) is a minimally invasive procedure introduced nearly two decades ago, but challenges around deployment accuracy and lengthy learning curves persist. Of the 1.7 million patients who need a TAVI procedure annually, only about 300,000 currently receive it in the US and EU. According to Frost & Sullivan, the global TAVI market exceeds $8 billion and is growing at double-digit rates annually. Caranx aims to close this treatment gap through AI-driven solutions that enable more cardiologists and centres to perform the complex procedure safely and effectively.

Tavipilot Soft uses AI to track anatomical and device landmarks in real-time, offering precise valve placement. It is compatible with all cardiac imaging systems and will work with all TAVI heart valves currently on the market.

“Our broader vision includes expanding our proprietary AI platform across other cardiovascular applications such as mitral and tricuspid valve replacement,” added Hansen. “We’re working with a dataset from over 5,000 annotated cases to fuel ongoing development.”

Founder Philippe Pouletty, also CEO of Truffle Capital, said, “Tavipilot Soft represents our mission to revolutionise medicine and make life-saving treatments more accessible. We're actively exploring strategic partnerships and scaling opportunities under an initiative we call CarvOlympics.”