TAVIPILOT

by Caranx Medical  · Based in France →Democratizing access to life-saving TAVI procedures with AI-driven precision.
Cardiology Cardiothoracic Surgery

Regulatory Status Disclosed

Overview

TAVIPILOT Soft by Caranx Medical is an innovative AI-driven intra-operative software designed to provide real-time guidance during Transcatheter Aortic Valve Implantation (TAVI/TAVR) procedures. This software tracks real-time anatomical and instrument landmarks, enabling precise and accurate heart valve positioning and delivery. Its primary goal is to enhance precision and expand access to complex TAVI procedures, allowing a broader number of cardiologists, including those with less experience, to perform these life-saving interventions effectively. TAVIPILOT Soft is compatible with all cardiac imaging systems and major TAVI heart valves currently on the market. Caranx Medical is also actively developing a TAVIPILOT Robotic solution, aiming for autonomous control in future transcatheter heart valve implantations.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-driven intra-operative software
  • Real-time guidance for TAVI/TAVR procedures
  • Tracks anatomical and instrument landmarks
  • Enables precise heart valve positioning and delivery
  • Compatible with all cardiac imaging systems
  • Compatible with all major TAVI heart valves
  • Aims to democratize access to TAVI procedures
  • Reduces operator variability
  • Supports safe and predictable valve deployment
  • Future autonomous robotic solution (TAVIPILOT Robotic)

Use Cases

  • Transcatheter Aortic Valve Implantation (TAVI/TAVR) guidance
  • Enhancing precision in heart valve positioning
  • Expanding access to complex cardiac procedures for less experienced cardiologists
  • Reducing procedure time and improving patient outcomes
  • Assisting interventional cardiologists and cardiac surgeons
  • Future autonomous robotic surgery

What Physicians Need to Know

Primary Function
AI-driven software for real-time intra-operative guidance during Transcatheter Aortic Valve Implantation (TAVI/TAVR) procedures.
Cardiac CT/MRI Analysis
Utilizes precise preoperative CT-scans for TAVI planning and its AI algorithms are trained on multimodality images, including CT data.
Echocardiography AI Features
AI algorithms are built on over 5,000 annotated multimodality images, including echocardiography data, to inform real-time guidance during TAVI.
Coronary Artery Assessment
Identifies key heart anatomical features, such as the Non-coronary Cusp (NCC), for precise valve placement during TAVI.
Cardiac Monitoring Integration
Compatible with all modern cardiac imaging systems and TAVR valves, providing real-time tracking of anatomical and instrument landmarks during procedures.
Real-Time Alert Capability
Offers real-time guidance and tracking, functioning like a 'GPS system' for TAVI procedures to enhance precision and improve patient outcomes.
Precision and Accuracy
Demonstrated millimetric precision and excellent accuracy in predicted valve positioning compared to final implanted positions in clinical use.
Regulatory Status
Received U.S. Food and Drug Administration (FDA) clearance for TAVIPILOT Soft, marking it as the first FDA-cleared software of its kind for real-time TAVR guidance.
Procedural Accessibility
Aims to democratize TAVI procedures by enabling a broader number of cardiologists, including those with less experience, to perform complex interventions safely and predictably.
Physician Tip

TAVIPILOT Soft can significantly enhance precision and safety during TAVI/TAVR procedures by providing real-time, AI-driven guidance. This tool is particularly beneficial for interventional cardiologists, especially those with less experience, as it helps to standardize valve positioning and delivery, potentially reducing procedural variability and improving patient outcomes. Leverage its compatibility with existing imaging systems for seamless integration into current workflows. The software's ability to track anatomical landmarks with millimetric precision can aid in complex cases and contribute to a shorter learning curve for new operators.

TAVIPILOT Soft is designed to be compatible with all modern cardiac imaging systems (including CT, fluoroscopy, and echocardiography) and the principal TAVI heart valves on the market. Caranx Medical is also developing an autonomous TAVIPILOT robot that will interact with the software, indicating future integration with robotic-assisted platforms to further enhance procedural control and automation.

Details

Category Cardiology AI, Surgical AI
Pricing Unknown
DeploymentSoftware, integrated with FDA-cleared X-ray systems
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

TAVIPILOT Soft received FDA clearance (K243884) on July 7, 2025, as an AI software tool intended to be used in combination with FDA-cleared X-ray systems to assist cardiac surgeons and interventional cardiologists with transcatheter aortic valve implantation (TAVI/TAVR) procedures.

Integrations
EHR Not specified
Specialties Cardiology, Cardiothoracic Surgery

What the Web Says

TAVIPILOT Soft is an AI-powered software developed by Caranx Medical for real-time intra-operative guidance during Transcatheter Aortic Valve Implantation (TAVI) procedures. It received FDA clearance in July 2025 and had its first clinical use in October 2025, with plans for early commercialization by the end of 2025. The software aims to enhance precision, improve patient outcomes, and make TAVI procedures more accessible to a broader range of cardiologists.

Overall: Positive

Strengths

  • Real-time intra-operative guidance for TAVI procedures.
  • Enhances precision and accuracy in heart valve positioning and delivery.
  • Potential to improve patient outcomes.
  • Aims to democratize TAVI procedures by making them accessible to more cardiologists.
  • Compatible with all cardiac imaging systems and main TAVI heart valves.
  • Demonstrated technical robustness and high investigator satisfaction in initial clinical use.

Limitations

  • Limited public reviews available outside of company press releases due to recent market introduction.
  • No independent tech reviewer, Reddit, G2, or Capterra reviews found yet.
  • The guidance is not intended to substitute the cardiac surgeon's or interventional cardiologist's judgment.

Based on reviews from: BioSpace, BioWorld, Medical Device and Diagnostic Industry (MPO), Business Wire, FDA (accessdata.fda.gov), Carvolix

Last updated: 2026-07-18

Ratings & Reviews

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Press & Coverage

Caranx Medical News / Cath Lab Digest
Caranx Medical Announces FDA Clearance of TAVIPILOT Soft: the World's First AI Software for Real-Time Intra-Operative Guidance of Transcatheter Heart Valve Implantation
Caranx Medical received FDA clearance for TAVIPILOT Soft, the first AI software for real-time intra-operative guidance of transcatheter heart valve implantation (TAVI). This software aims to enhance precision and improve patient outcomes in TAVI procedures, with commercialization planned by the end of 2025.
2025-07
Business Wire
Caranx Medical Announces First Clinical Use of the TAVIPILOT Soft, Cleared by FDA for Commercial in July: the World First AI Software for Real-Time Intra-Operative Guidance of Transcatheter Heart Valve Implantation
Caranx Medical announced the first clinical use of TAVIPILOT Soft in France, demonstrating its feasibility, safety, and technical robustness during TAVI procedures. The study confirmed the software's potential to enhance precision and improve patient outcomes, with early commercialization in the US expected by the end of 2025.
2025-11
Medical Economics
Caranx Medical wins FDA Clearance for AI heart valve guidance software
Caranx Medical's TAVIPILOT Soft, an AI-powered software, received FDA clearance to enhance precision in TAVI procedures by providing real-time intra-operative guidance. The system is compatible with all cardiac imaging systems and TAVI heart valves, aiming to make TAVI more accessible to a broader number of cardiologists.
2025-07
BioWorld
Caranx Medical gets FDA nod for TAVR software Tavipilot Soft | BioWorld
Caranx Medical secured FDA clearance for Tavipilot Soft, its AI-powered software designed to provide real-time intraoperative guidance during transcatheter heart valve replacement (TAVR) procedures. The software tracks anatomical and instrumental landmarks to enable precise valve positioning and delivery, aiming to expand access to this complex procedure.
2025-07
Imaging Technology News
FDA OKs Caranx's Tavipilot Soft Real-Time Guidance During TAVI
Caranx Medical received FDA clearance for Tavipilot Soft, the world's first AI software for real-time, intra-operative guidance of TAVI. This AI-driven software tracks anatomical and instrument landmarks for precise heart valve positioning and delivery, aiming to revolutionize TAVR procedures currently limited to highly experienced cardiologists.
2025-07
Pienomial (via WeChat)
The world's first AI navigation system for TAVI surgery has been approved by the FDA
Caranx Medical's TAVIPILOT Soft, the world's first AI system for real-time guidance during TAVI surgery, has received FDA approval. It is expected to launch in the US market by the end of 2025, aiming to enhance valve implantation precision and improve patient outcomes.
2025-08
Truffle Capital
Caranx Medical announces FDA clearance of TAVIPILOT Soft - Truffle Capital
Truffle Capital announced that its project company, Caranx Medical, received FDA approval for TAVIPILOT Soft, an AI software designed for heart valve placement.
2025-07
Truffle Capital
Caranx first clinical use in patients of TAVIPILOT Robot in Australia - Truffle Capital
Caranx Medical, a Truffle Capital project company, announced the first clinical use of its TAVIPILOT Robot in Australia. This marks a significant step in the development of their autonomous robot for improving efficiency and safety in TAVI procedures.
2025-12

Videos

Product demos, reviews, and walkthroughs for TAVIPILOT.

View all on YouTube

Frequently Asked Questions

TAVIPILOT Soft is an AI-driven intra-operative software that provides real-time guidance during TAVI/TAVR procedures by tracking anatomical and instrument landmarks. This enables precise and accurate heart valve positioning and delivery, aiming to simplify the procedure and make it accessible to a broader range of cardiologists.
TAVIPILOT Soft received FDA clearance for US commercialization in July 2025, making it the world's first AI software for real-time intra-operative guidance of transcatheter heart valve implantation. This clearance was a significant milestone for Caranx Medical.
No, the guidance provided by TAVIPILOT Soft is not intended to substitute the cardiac surgeon's or interventional cardiologist's judgment and analysis of the patient's condition. It serves as a tool to enhance precision and improve patient outcomes.
While TAVIPILOT Soft is noted as the world's first AI software for real-time intra-operative guidance in TAVI, other AI-based software that assists with TAVR procedures include Hi-D Imaging's 4TAVR, Royal Philips NV Heartnavigator, and DASI Simulations' Precision TAVI. TAVIPILOT Soft is compatible with all cardiac imaging systems and most TAVI heart valves on the market.
Caranx Medical planned for the market introduction of TAVIPILOT Soft by the end of 2025, following its first clinical use in October 2025. The software is expected to revolutionize transcatheter aortic valve replacement by allowing more cardiologists to perform the procedure safely and predictably, addressing the significant number of patients in need of TAVI.
Caranx Medical has ambitions to become a global leader in AI and robotic-assisted transcatheter heart valve implantation, with an autonomous TAVIPILOT robot currently under development. This robotic solution is intended to interact with TAVIPILOT Soft to further democratize access to TAVI procedures and potentially expand to other cardiovascular indications like mitral and tricuspid valve replacements.
While specific training details are not extensively outlined, the software is designed to be easy-to-use and aims to reduce the long learning curves associated with TAVI procedures, thereby allowing a broader number of cardiologists to perform them. The goal is to promote safe and predictable valve deployment even for less experienced practitioners.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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