Caranx Medical has received FDA 510(k) clearance for its TaviPilot AI software, a key component of its robotic TAVI/TAVR surgical platform. TaviPilot uses real-time AI to guide transcatheter aortic valve procedures by detecting key anatomy and tracking valve placement, even amid heartbeat and breathing motion.
The system enables robotic artery puncture, instrument navigation, and precise valve delivery using CT-based preoperative planning and fluoroscopy during the procedure. According to CTO Pierre Berthet-Rayne, TaviPilot is the first AI cleared for real-time anatomical tracking under physiological motion in interventional cardiology.
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