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BioWorld - Tuesday, June 16, 2026
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Home » Caranx Medical gets FDA nod for TAVR software Tavipilot Soft
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Caranx Medical gets FDA nod for TAVR software Tavipilot Soft

July 16, 2025
By Shani Alexander
Caranx Medical SAS secured clearance from the U.S. FDA for Tavipilot Soft, its AI-powered software which provides real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software, which tracks anatomical and instrumental landmarks in real-time to enable precise and accurate heart valve positioning and delivery, will allow a broader number of cardiologists to perform this complex procedure.
Medical technology Regulatory Cardiovascular Europe U.S. 510(k) FDA

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