Carvolix Files 510(k) Application with FDA for Its Tavipilot Robot
The medical technology company, formerly Affluent Medical, is taking a regulatory step ahead of the United States commercialization of its integrated TAVIPILOT platform, which it aims to launch across the Atlantic in early 2027.
A Platform Combining Software and Robot for TAVI Procedures
Carvolix announced on September 22, 2026 the filing of a 510(k) application with the American Food and Drug Administration (FDA) for the TAVIPILOT robot, the robotic component of its integrated platform intended for transcatheter aortic valve replacement procedures (TAVI).
The TAVIPILOT platform brings together two elements: the TAVIPILOT software, a real-time artificial intelligence guidance tool that obtained FDA 510(k) authorization in July 2025 and is already marketed in the United States, and the TAVIPILOT robot, which ensures catheter stability and millimeter-precision control under the supervision of the operator.
Subject to FDA approval, Carvolix confirms its objective to launch the integrated platform in the United States in early 2027. This step also brings the company closer to drawing the second tranche of €10 million from the €30 million structured debt facility concluded with Claret Capital, conditioned on FDA authorization of the robot.
The Filing Supported by the ROTAO1 Study and Continued SAIRO Study
The filing comes after the completion of the ROTAO1 study, the first human study, which evaluated the TAVIPILOT robot in 10 patients with symptomatic severe aortic stenosis during transfemoral TAVI procedures. According to the company, the system functioned in all 10 procedures, with no serious adverse events considered related to the robot, and all 10 patients completed their one-month follow-up without death or study withdrawal.
The study was conducted by Professor Stephen Worthley and his team at Macquarie University Hospital in Sydney. Carvolix is also continuing clinical development of the platform with the SAIRO study, which evaluates the combined use of the robot and TAVIPILOT software: an interim analysis covers the first 7 of the planned 20 patients, all treated successfully.
The company also notes reliance on the evolution of the American regulatory environment. On September 10, 2026, the Centers for Medicare & Medicaid Services (CMS) published their final national coverage decision for TAVI, relaxing certain conditions for access to procedures, in particular the removal of hospital volume thresholds and the possibility of performing the intervention by a single operator.
