on Affluent Medical (isin : FR0013333077)
Carvolix is preparing the European launch of TAVIPILOT following regulatory filing
Carvolix, a French medical technology company, announces the filing of the regulatory dossier for the TAVIPILOT software in August 2026. This step aims to obtain CE marking, anticipated by the end of 2026. This software, intended for the guidance of aortic procedures, should be launched in early 2027 in Europe, after a successful launch in the United States.
The European development will initially target France and Germany, supporting the technological integration within medical teams. In the United States, the software has already demonstrated its effectiveness with ten patients treated at Rush University Medical Center in Chicago.
With growing experience and recognition at medical congresses, Carvolix is evaluating the positive medical-economic impact of TAVIPILOT, based on successful trials in Australia and France.
R. E.
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