Caranx Medical, a French medtech company based in Nice, has received U.S. FDA clearance for the world’s first AI-powered software for real-time intraoperative guidance during transcatheter aortic valve implantation (TAVI).
This marks a significant regulatory milestone for Caranx and for France: it is the first time an AI software from a French company has been approved for real-time surgical guidance in a cardiac procedure — an achievement shared by only a few French medtech firms, such as Quantum Surgical, Bioserenity, and Sublimed.
Backed by Truffle Capital, a major European life sciences investor, and led by a team of seasoned executives and clinical experts, Caranx Medical is developing a robotic and AI-assisted platform to democratize access to complex cardiac valve procedures. Co-founded by Dr. Philippe Pouletty (also Managing Partner at Truffle Capital), Dr. Eric Sejor (CMO), and Pierre Berthet-Rayne (CTO), Caranx aims to become a global leader in robotic TAVI procedures.
Caranx was established in Nice in 2021 with the support of Team Nice Côte d’Azur, and was a winner of the i-Nov Innovation Contest in the health category.
A strategic milestone for Caranx Medical
The FDA authorization paves the way for commercial launch of TAVIPILOT Soft by the end of 2025.
A major breakthrough for TAVI procedures
“The FDA approval of TAVIPILOT Soft is a major milestone for the Caranx team,” says Jorgen Hansen, CEO of Caranx. “This clearance confirms the potential of real-time guidance in TAVI/TAVR procedures to enhance precision and improve patient outcomes. We are excited to move toward early commercialization by the end of 2025 and to provide interventional teams with a solution that enables safe and predictable valve deployment.”
A growing clinical need and a fast-expanding market
TAVI, developed two decades ago, remains a technically demanding procedure with a steep learning curve, requiring high levels of precision. While around 300,000 TAVI procedures are performed annually in the US and EU, 1.7 million patients are currently eligible. According to Frost & Sullivan, the TAVI market is valued at $8 billion annually and continues to grow at a double-digit rate.
Caranx’s products aim to expand access to TAVI procedures and enable a broader range of interventional cardiology centres to perform them safely.
Expanding AI platform for future cardiovascular indications
“At Caranx Medical, our vision extends to the development of our proprietary artificial intelligence platform, built using data from over 5,000 patients with annotated multimodal imaging (CT, fluoroscopy, echo, data, etc.), which fuels our AI algorithms to revolutionize other cardiovascular indications, such as mitral and tricuspid valve replacements, thereby reshaping the landscape of minimally invasive interventional medicine,” adds Jorgen Hansen, CEO of Caranx.
A mission to save lives and transform medicine
“Our mission, as entrepreneurs and company builders, is to save lives and revolutionize medicine. To achieve this, we aim to enable more cardiologists and interventional cardiology centers to perform complex procedures like TAVI, using Caranx’s AI-powered software and autonomous robot,” explains Dr. Philippe Pouletty, founder of Caranx and Managing Partner at Truffle Capital. “We are exploring ways to make Caranx’s future even more promising and ambitious, particularly through potential collaborations with other cardiovascular medtech companies, as part of an ambitious initiative called CarvOlympics.”
TAVIPILOT Soft: simple, compatible, and AI-powered
TAVIPILOT Soft is an easy-to-use, AI-powered intraoperative software that tracks anatomical and instrumental landmarks in real time. It enables clinicians to position the heart valve with precision.
TAVIPILOT Soft could revolutionize transcatheter aortic valve replacement, which is currently limited to the most experienced cardiologists and surgeons. TAVIPILOT Soft is compatible with all cardiac imaging systems and will support the leading TAVI heart valves on the market.
Source: Caranx Medical
A thriving health innovation ecosystem in Nice Côte d’Azur
The region’s attractiveness in the health sector is built on a well-structured ecosystem combining cutting-edge infrastructure, academic excellence, and a thriving entrepreneurial environment. The Nice University Hospital (CHU), in partnership with Université Côte d’Azur, leads major projects such as IHU RespirERA, dedicated to chronic respiratory diseases. Selected in 2023 under the France 2030 programme, this university hospital institute is one of only 12 projects approved at the national level out of over 90 applications, reinforcing Nice’s strategic position in precision medicine and technological innovation.
This ecosystem also includes the Skin Institute, focused on digital dermatology, and 3IA Côte d’Azur, which develops AI applications in healthcare, such as biomarkers, digital twins, and predictive medicine.
Université Côte d’Azur plays a central role in this momentum, notably through the Nucleate France UniCA programme, which supports the transition of PhD students into life sciences entrepreneurship. In parallel, the upcoming spin-off Dimicare—born from UniCA, INSERM, and CNRS—is developing a new class of targeted antibiotics identified through the ARROW high-throughput screening platform.
This scientific energy is supported by a network of innovative startups such as Algenscribe (genomic medicine), Roca Therapeutics (biotechnology), ExAdEx-Innov (adipose tissue-based therapies), and Klava Innovation (smart medical devices).
In 2025, Caranx Medical, a medtech company based in Nice, received FDA approval for the first AI software enabling real-time guidance for transcatheter heart valve implantation. This technological breakthrough further strengthens the Côte d’Azur’s position as a leading hub for digital health and AI-assisted surgery.
The entire ecosystem benefits from strategic support through Eurobiomed, the interregional competitiveness cluster, and enjoys strong international visibility enhanced by strategic partnerships.
