Carvolix Seeks US FDA Nod for AI-Guided Tavipilot Robot

12:34 AM EDT, 09/23/2026 (MT Newswires) -- Carvolix (CVX.PA) submitted a 510(k) application to the US Food and Drug Administration for the Tavipilot Robot, the robotic component of its platform for transcatheter aortic valve replacement procedures. The robot uses artificial intelligence-driven technology to provide catheter stability and millimetric precision control under the operator's supervision, the French medical technology company said in a Tuesday release. The US FDA clearance is a condition for the company to draw the second 10 million-euro tranche under a 30 million-euro structured debt facility secured with Claret Capital. If approved, Carvolix plans to commercially launch the platform in the US by early 2027.