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Carvolix Seeks Marketing Authorization in EU for Tavipilot Software

MT Newswires·09/10/2026 00:28:18
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12:28 AM EDT, 09/10/2026 (MT Newswires) -- Carvolix (CVX.PA) said Wednesday that it filed an application to market its Tavipilot Software in the European Union. The French medical technology company submitted the regulatory dossier for the artificial intelligence software in August 2026. It expects to receive CE marking by the end of 2026, with commercial launch targeted for early 2027. The software is designed for intraoperative guidance of transcatheter aortic valve replacement procedures. Carvolix said efforts to commercialize the product in the US are also advancing, with the main stages of clinical and regulatory processes already completed. US commercial launch is also expected by early 2027.