Carvolix: CE marking file submitted for its cardiac valve placement assistance software

CE file submitted in August 2026, marking expected by end of 2026

Carvolix announced that it submitted in August 2026 the regulatory file for Tavipilot Software in order to obtain CE marking. Subject to completion of the evaluation process, CE marking is expected by the end of 2026, paving the way for commercial deployment of the software in Europe. "We have a clear trajectory toward CE marking of Tavipilot Software and toward its commercial deployment in Europe, expected for early 2027," declared Sébastien Ladet, Chief Executive Officer of Carvolix. He linked this phase to the success of the platform presentation at the EuroPCR congress in May 2026 and to initial commercial experiences in the United States.

Launch planned in France and Germany, ten patients treated in the United States

Carvolix plans to begin commercial launch of Tavipilot Software in early 2027, focusing initially on France and Germany, presented by the company as two of the most important markets in Europe for TAVI procedures (transcatheter aortic valve replacement). This progressive development strategy aims to support adoption of the technology by medical teams, to document its use in real-world conditions, and to establish a community of reference user centers. The company has undertaken to strengthen its commercial resources, with the recruitment of a team dedicated to the European market. It is also preparing the integration of the Tavipilot robot in Europe for the second half of 2027. In the United States, where the software obtained FDA 510(k) authorization in July 2025, the first commercial contract was concluded with Rush University Medical Center in Chicago, whose team recently treated ten patients.