TAVIPILOT

by Carvolix  · Based in France → — Democratizing complex cardiac and brain stroke interventions with AI-driven mini-robotics
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

Cardiac CT/MRI Analysis
TAVIPILOT uses previously acquired DICOM cardiac CT patient data for planning and guides the procedure using a 2D projection of aortic root-related landmarks on X-ray images. The AI platform is being developed with a database of over 5000 annotated multimodality images, including CT, Fluoroscopy, and Echo data.
Real-Time Alert Capability
TAVIPILOT provides real-time fluoroscopy detection, tracking, and marking of the Non-Coronary Cusp (NCC) and the prosthetic valve to guide precise positioning during TAVI/TAVR procedures. The software offers continuous visualization of anatomical landmarks and the prosthetic valve, along with live implant depth guidance with millimetric precision. It has demonstrated robustness to patient cardiac motion, breathing motion, and C-arm/table motion.
Coronary Artery Assessment
TAVIPILOT has a high accuracy in detecting, tracking, and marking the Non-Coronary Cusp (NCC) within ≤ 2 mm in 100% of tested patients, with statistical significance. This accuracy was observed in both contrasted and non-contrasted images.
Physician Tip

TAVIPILOT is designed to enhance precision and standardize TAVI procedures, potentially reducing the learning curve for less experienced cardiologists. The software provides real-time guidance, acting like a 'GPS system' for valve deployment, which can improve safety and predictability. Clinicians should integrate TAVIPILOT into their existing workflow to leverage its real-time anatomical landmark visualization and implant depth guidance for more confident decision-making during valve positioning. It is compatible with all cardiac imaging systems and major TAVI heart valves, making it broadly applicable.

TAVIPILOT is an intra-operative software compatible with all cardiac imaging systems and major TAVI heart valves on the market. It connects to interventional (C-arm) X-ray systems and utilizes previously acquired DICOM cardiac CT patient data. The software integrates into existing workflows, providing real-time visual guidance to support precise valve positioning during TAVI.

Details

Category Cardiology AI, Surgical AI
Pricing Unknown
DeploymentThe TAVIPILOT Software began commercial deployment in the United States in H2 2025 through a targeted customer launch. The integrated TAVIPILOT platform (Software and Robot) is planned for commercial launch in the US in early 2027. Carvolix plans to launch TAVIPILOT Software in Europe, initially in France and Germany, in early 2027, with the platform including the robot expected in Europe in the second half of 2027.
TrainingUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
GDPR Yes AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Cardiothoracic Surgery

Support & Reliability

Training ProvidedUnknown

What the Web Says

TAVIPILOT, developed by Caranx Medical, is an AI-driven intra-operative software designed to provide real-time guidance for Transcatheter Aortic Valve Implantation (TAVI/TAVR) procedures. It aims to enhance precision in valve positioning, making the complex procedure more accessible to a broader range of cardiologists. The software has received FDA 510(k) clearance and has shown high accuracy in detecting and tracking anatomical features and prosthetic valves during initial clinical use.

Overall: Positive

Strengths

  • Provides real-time guidance during TAVI/TAVR procedures.
  • Enhances precision and accuracy of heart valve positioning and delivery.
  • Aims to lower the barrier for performing TAVI, allowing more cardiologists to perform the procedure.
  • Compatible with all cardiac imaging systems and principal on-market TAVI valves.
  • Demonstrated high accuracy in detecting and tracking anatomical landmarks and prosthetic valves in clinical trials.
  • Designed to be user-friendly and integrate seamlessly into usual clinical practice.

Limitations

  • The TAVIPILOT robot, which interacts with the software, is still under development.
  • Currently, the software is cleared for the US territory only.
  • The guidance provided is not intended to substitute the cardiac surgeon's or interventional cardiologist's judgment.
  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra, as it is a specialized medical device recently cleared by the FDA.

Based on reviews from: massdevice.com, fda.gov, ortoday.com, surgicalroboticstechnology.com, veeva.com, carvolix.eu, businesswire.com, cardiovascularnews.com, cardiovascularbusiness.com, youtube.com, mddionline.com, medicaldevice-network.com, xogene.com, clinicaltrials.gov, g2.com

Last updated: 2026-10-29

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Press & Coverage

ritzau.dk
Caranx Medical Announces FDA Submission of TAVIPILOT Soft: the World's first AI Software for Real-time Intra-operative Guidance of Transcatheter Heart Valve Implantation.
Caranx Medical announced the FDA submission of TAVIPILOT Soft, an AI software for real-time intra-operative guidance during transcatheter heart valve implantation (TAVI). This submission is a significant step towards planned market introduction by the end of 2025.
2025-01
medicaldevice-network.com
Caranx Medical submits AI TAVI-TAVR guide software to FDA
Caranx Medical submitted TAVIPILOT Soft, an AI-based guide software for Transcatheter Aortic Valve Implantation (TAVI) or replacement procedures (TAVR), to the US FDA for approval. The company claims it's the first solution of its kind to track real-time anatomical and instrument landmarks for precise heart valve positioning.
2025-01
medicaleconomics.com
Caranx Medical wins FDA Clearance for AI heart valve guidance software
Caranx Medical received U.S. Food and Drug Administration (FDA) clearance for its AI-powered TAVIPILOT Soft software, designed to provide real-time intra-operative guidance for transcatheter aortic valve implantation (TAVI) procedures. This system aims to enhance precision and improve patient outcomes, with early commercialization expected by the end of 2025.
2025-07
biospace.com
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 announced FDA clearance for TAVIPILOT Soft, the world's first AI software for real-time intra-operative guidance of transcatheter heart valve implantation. This clearance is a significant milestone for the company's strategy towards market introduction by the end of 2025.
2025-07
cardiovascularbusiness.com
FDA clears AI-powered software for real-time TAVR guidance
Caranx Medical received U.S. Food and Drug Administration (FDA) clearance for TAVIPILOT Soft, an AI offering that provides real-time guidance during transcatheter aortic valve replacement (TAVR) procedures. This software is designed to help more cardiologists perform TAVR and achieve strong patient outcomes.
2025-07
businesswire.com
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, following its FDA clearance in July. The SAITO-1A study demonstrated the software's feasibility, safety, and technical robustness in TAVI procedures, with plans for U.S. market introduction by the end of 2025.
2025-11
massdevice.com
Caranx announces first clinical use of autonomous robot for TAVI
Caranx Medical announced the first clinical use of its TAVIPILOT Soft platform for robotic transcatheter aortic valve implantation (TAVI) at Clinique Pasteur in France. The SAITO-1A study demonstrated the software's ability to track real-time anatomical and instrument landmarks for precise heart valve positioning.
2025-11
carvolix.eu
Carvolix submits 510(k) for TAVIPILOT Robot, advancing toward US commercial launch of Its Integrated TAVIPILOT Platform.
Carvolix announced the filing of a 510(k) submission with the U.S. FDA for the TAVIPILOT Robot, the robotic component of its integrated TAVIPILOT platform. This regulatory step is crucial for the planned U.S. launch of the integrated platform in early 2027, following the successful ROTAO1 First-in-Human study.
2026-09

Videos

Product demos, reviews, and walkthroughs for TAVIPILOT.

View all on YouTube

Frequently Asked Questions

TAVIPILOT is an AI-driven intra-operative software developed by Caranx Medical that provides real-time visual guidance for precise valve positioning during Transcatheter Aortic Valve Implantation (TAVI) procedures. It tracks anatomical landmarks and the prosthetic valve, offering live implant depth guidance with millimetric precision. This technology aims to enhance precision, standardize procedural outcomes, and potentially make TAVI more accessible to a broader range of cardiologists and centers.
TAVIPILOT Soft has received FDA clearance, making it the first AI software cleared for real-time tracking of anatomical features during a live interventional cardiology procedure under physiological motion. Users must be clinical specialists, such as cardiac surgeons or interventional cardiologists, who are fully skilled and qualified to perform TAVI/TAVR procedures. Before use, required training in the safe and effective operation of the device must be completed, and certification is necessary to operate TAVIPILOT.
While TAVIPILOT Soft is noted as the first FDA-cleared AI software for real-time intra-operative guidance in TAVI, Caranx Medical's vision extends to developing its AI platform for other cardiovascular indications, such as mitral and tricuspid valve replacements. Other AI-driven tools are also being developed for various cardiovascular interventions, including mitral and tricuspid interventions and vascular access optimization. For example, Philips HeartNavigator 2.0 is mentioned as a predicate device in the FDA clearance for TAVIPILOT.
TAVIPILOT is currently indicated for adult patients (21 years and older). The guidance provided by TAVIPILOT is not intended to substitute the clinical judgment and analysis of the patient's condition by the cardiac surgeon or interventional cardiologist, and it must be used in conjunction with other methods of assessing clinical signs and symptoms. No modification of TAVIPILOT is allowed.
TAVIPILOT is expected to revolutionize transcatheter aortic valve replacement by allowing a broader number of cardiologists and interventional cardiology centers to perform complex TAVI procedures. By enhancing precision and potentially shortening the learning curve for newer physicians, it aims to increase patient access to this life-saving therapy, especially given that a significant number of eligible patients currently do not receive TAVI.

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