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# Caranx AI Valve Replacement Software Cleared
- URL: https://www.fdaweb.com/caranx-ai-valve-replacement-software-cleared/
- Published: 2025-07-16T12:00:00.000Z
- Updated: 2026-09-14T15:16:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159520

FDA has cleared a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operative guidance for transcatheter heart valve implantation. The device is intended to enhance implant procedure precision and improve patient outcomes, according to the company, adding that the “easy-to-use, AI-driven intra-operative software tracks in real-time anatomical and instrument landmarks.”

Caranx says the TAVI procedure (minimally invasive transcatheter aortic valve replacement) was introduced about 20 years ago, and cardiologists still face critical challenges and long learning curves during these procedures to accurately and precisely deploy heart valves. TaviPilot Soft is based on Caranx’s proprietary Artificial Intelligence Platform that includes “more than 5,000 patients with annotated multimodality images of CT, fluoroscopy, echo, data, etc. used to feed our AI algorithms,” according to the company.