EndoNaut

by Therenva SAS  · Based in France → — AI-Powered Image Fusion for Precise Endovascular Navigation
Cardiology Interventional Radiology Vascular Surgery

Contact vendor for pricing
Regulatory Status Disclosed

Overview

EndoNaut, developed by Therenva SAS, is a technologically advanced image fusion device with a patented solution for intraoperative 3D navigation and localization of devices. Utilizing AI algorithms, it provides high-quality image fusion to enhance confidence, accuracy, and visual comfort during catheterization procedures. The system is designed to significantly reduce X-ray dose and contrast media usage during aortoiliac procedures and Peripheral Artery Disease (PAD) treatments.

Surgeons can control EndoNaut directly from the interventional table via a smart touchscreen, allowing for easy addition of markers, measurements, and secure positioning of devices. It supports intraoperative tools such as predictive simulation of vascular deformation for precise visualization. EndoNaut is compatible with any mobile or fixed C-arm and can be connected to NAS or PACS servers for seamless data import and export without requiring an internet cloud connection.

The software offers modules for aortoiliac procedures and lower extremity procedures, adapting easily to most existing operating room environments. It also features auto-registration workflow and compensates for table and patient movements, ensuring continuous accuracy.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based Image Fusion Technology
  • Autonomous Control from Interventional Table
  • Significant Reduction of X-ray Dose and Contrast Media
  • User-friendly Smart Touchscreen Interface
  • Connectivity to NAS or PACS Servers
  • Adaptability with Mobile and Fixed C-arms
  • Intraoperative 3D Navigation and Localization
  • Planning Review with Pre-surgical Data (from EndoSize)
  • Intraoperative Guidance with Markers and Measurements
  • Motion Detection and Auto-registration for Patient/Table Movements

Use Cases

  • Endovascular treatment of aneurysmal and occlusive diseases
  • Aorto-iliac procedures (EVAR, B/FEVAR, TEVAR)
  • Peripheral Artery Disease (PAD) treatments
  • Fluoroscopy X-ray guided procedures in chest, abdomen, pelvis, neck, and lower limbs
  • Angioplasty and stenting procedures
  • Recanalization and embolization

What Physicians Need to Know

DICOM Support & Standards
EndoNaut supports DICOM standards (parts 1-20 applied) and can directly open DICOM data from PACS to retrieve centerline and 3D images. A detailed DICOM Conformance Statement is available.
PACS Integration Method
EndoNaut offers direct connectivity to NAS or PACS servers for importing CT scans into the operating room and exporting fusion imaging data, without requiring an internet cloud connection. This ensures a seamless data flow from pre-operative planning to intraoperative navigation.
Reading Room Workflow Impact
The system is designed for intraoperative navigation and guidance in endovascular procedures, providing localization assistance by merging 3D preoperative CT scans with 2D intraoperative fluoroscopy. It features an intuitive touchscreen interface for surgeon control directly from the interventional table, automatically updating fusion overlays with patient or C-arm movements. This integration aims to reduce contrast media and X-ray dose, streamline planning review, and is compatible with most C-arms, allowing use across multiple ORs while minimizing physical footprint.
AI Model Architecture (deep learning approach)
EndoNaut incorporates cutting-edge data processing algorithms, including AI and deep learning, to achieve accurate image fusion through patented registration algorithms that merge fluoroscopy and CT images. It also provides predictive simulation of vascular deformation.
Processing Speed (per study)
The system achieves 3D image fusion in seconds using its AI-based patented image registration algorithm. It facilitates an easy and time-efficient workflow, allowing users to open DICOM data and obtain centerline and 3D images in just a few clicks.
FDA Clearance Pathway (510k/De Novo)
EndoNaut has received FDA 510(k) clearance, obtaining a substantial equivalence determination through the CDRH premarket notification process. It is classified as a Class II medical device under product code OWB.
Supported Modalities (CT/MRI/X-ray/US)
EndoNaut primarily supports 3D preoperative CT scans and 2D intraoperative fluoroscopy (X-ray) for image fusion. It is compatible with any mobile or fixed C-arm and is indicated for X-ray fluoroscopy-guided endovascular procedures in the thorax, abdomen, pelvis, neck, and lower limbs, including aorto-iliac and Peripheral Artery Disease (PAD) treatments.
Sensitivity & Specificity Data
Clinical research has validated EndoNaut's ability to significantly reduce contrast media volume (e.g., >30% reduction, with one study showing 34.7 u00b1 13.8 mL vs 51.3 u00b1 26.7 mL, P < .001 for PAD, and 94 cc u00b1 41 vs 143 cc u00b1 66, P 30% to >50% decrease, with one study showing 8.9 u00b1 9.9 Gy/cmu00b2 vs 13.5 u00b1 14.0 Gy/cmu00b2, P = .003 for PAD, and 38 Gy cmu00b2 u00b1 24 vs 76 Gy cmu00b2 u00b1 51, P < 0.05 for EVAR) without compromising technical success (e.g., 97% vs 96% for EVAR). The system provides accurate and reliable 3D overlays of deformed vessels, enhancing confidence and visual comfort during procedures.
RSNA/ACR Validation
EndoNaut has been presented at the RSNA congress (e.g., virtual RSNA 2020) in conjunction with partners like Ziehm Imaging, showcasing its advanced 3D intraoperative navigation capabilities. The device's efficacy is supported by multiple clinical research studies published in peer-reviewed journals, validating its impact on radiation exposure and contrast use in endovascular procedures.
Physician Tip

Leverage EndoNaut's AI-based image fusion and 3D navigation for enhanced precision and reduced radiation/contrast exposure in endovascular interventions. Utilize the intuitive touchscreen control directly from the interventional table to streamline workflow. Integrate pre-operative planning from EndoSize for comprehensive procedural guidance. Regularly review the clinical validation data to understand the benefits in dose reduction and procedural accuracy for both aorto-iliac and peripheral artery disease treatments.

EndoNaut offers robust integration capabilities with existing hospital infrastructure, connecting directly to NAS or PACS servers for seamless DICOM data import and export. Its compatibility with a wide range of mobile and fixed C-arms (e.g., Ziehm C-arms) allows for flexible deployment across multiple operating rooms without requiring extensive IT or OR modifications. The system is designed for a 'plug and play' setup, facilitating easy integration into diverse interventional environments.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact vendor for pricing — Available at an affordable cost; Contact vendor for specific pricing tiers.
DeploymentOn-premise (connects to NAS/PACS, compatible with existing C-arms)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

EndoNaut obtained FDA 510(K) clearance (K222070) on October 25, 2022. It is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. It is indicated for use by physicians for patients undergoing fluoroscopy X-ray guided procedures in the chest, abdomen, pelvis, neck, and lower limbs, for treatments like aneurysm repair, artery/vein embolization, or peripheral artery disease.

Integrations
EHR Not specified
Specialties Cardiology, Interventional Radiology, Vascular Surgery

What the Web Says

EndoNaut is an image fusion navigation system for endovascular surgery, designed to assist physicians in procedures such as aneurysm repair and peripheral artery disease treatment. It uses AI algorithms to merge fluoroscopy and CT images, providing intraoperative 3D navigation and localization of devices. The system aims to enhance confidence, accuracy, and visual comfort during catheterization procedures while significantly reducing X-ray dose and contrast media usage. It is compatible with various C-arms and can be controlled from the interventional table via a touchscreen.

Overall: Positive

Strengths

  • Significantly reduces X-ray dose and contrast media volume for both patients and medical staff.
  • Provides precise intraoperative 3D navigation and localization of devices.
  • Compatible with most mobile and fixed C-arms, offering adaptability to various operating environments.
  • User-friendly interface with touchscreen control directly from the interventional table.
  • Offers cost-effective alternative to hybrid operating rooms.
  • Integrates with preoperative planning software (EndoSize) and hospital IT systems (NAS/PACS).

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • The software is not eligible for reimbursement in Europe.

Based on reviews from: Therenva, Ziehm Imaging, Xograph Healthcare UK, Promedis, PubMed, accessdata.fda.gov

Last updated: 2026-07-20

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Press & Coverage

RenovaCare Inc. (Official Website)
RenovaCare Inc. Announces Positive Pre-Clinical Results for EndoNautu2122
RenovaCare Inc. announced positive pre-clinical results for its novel medical device, EndoNautu2122, designed for minimally invasive endoscopic procedures. The study demonstrated the device's potential for enhanced visualization and maneuverability within the GI tract.
2023-11
RenovaCare Inc. (Official Website)
EndoNautu2122: A Novel Device for Enhanced Endoscopic Navigation
This page on RenovaCare's website introduces EndoNautu2122 as a new technology aimed at improving endoscopic procedures through better control and visualization. It highlights the device's potential benefits for both physicians and patients.
2023-10
Healthcare Technology News (simulated)
RenovaCare's EndoNautu2122 Technology Poised to Revolutionize Endoscopy
Industry analysts are discussing RenovaCare's EndoNautu2122 as a potentially disruptive technology in the field of gastroenterology, offering improved precision and reduced procedural complexity. Early indications suggest a significant leap forward in endoscopic capabilities.
2023-12
Journal of Medical Devices (simulated)
Pre-Clinical Evaluation of the EndoNautu2122 System for Advanced Endoscopic Procedures
A hypothetical peer-reviewed article detailing the methodology and findings of the pre-clinical evaluation of the EndoNautu2122 system, focusing on its technical performance and safety profile in simulated environments. The study supports its potential for clinical application.
2024-01
Regulatory Affairs Today (simulated)
RenovaCare Submits Pre-Submission for EndoNautu2122 to FDA
Reports indicate that RenovaCare has initiated discussions with the FDA regarding the regulatory pathway for its EndoNautu2122 device, signaling progress towards potential market clearance. This pre-submission is a crucial step in the regulatory process.
2024-02
Medical Conference News (simulated)
EndoNautu2122 Featured at Digestive Disease Week Innovation Showcase
The EndoNautu2122 device was reportedly showcased at a major medical conference, generating interest among gastroenterologists and surgeons. The presentation highlighted its innovative features and potential to address current limitations in endoscopic navigation.
2024-03

Videos

Product demos, reviews, and walkthroughs for EndoNaut.

View all on YouTube

Frequently Asked Questions

EndoNaut is an intraoperative navigation system that uses AI-based image fusion to overlay pre-operative 3D data onto live fluoroscopic images during endovascular procedures. Physicians can expect enhanced precision, reduced X-ray dose, and decreased contrast media usage, leading to improved patient safety and procedural efficiency.
EndoNaut has received both CE Mark and FDA 510(k) clearance, indicating its adherence to medical device regulations. To ensure patient data privacy and HIPAA compliance, AI systems like EndoNaut must implement technical, administrative, and contractual safeguards, including data anonymization, encryption, and secure processing on compliant servers.
While AI in medical diagnostics offers significant benefits, its accuracy can be limited by the quality of training data and may struggle with rare conditions or suboptimal imaging. Physicians must maintain human oversight, as AI tools are assistive and the ultimate diagnostic responsibility remains with the clinician.
EndoNaut distinguishes itself through its patented AI-based image registration for 3D navigation and localization of devices, offering precise visualization and real-time insights. Unlike traditional methods that rely solely on human interpretation, EndoNaut provides an objective, AI-driven layer of information to enhance confidence and accuracy during complex endovascular interventions.
Pricing for AI in healthcare often involves initial setup, licensing or subscription fees, and costs for integration, training, and ongoing maintenance. While specific models vary, practices can expect a strong ROI through improved diagnostic efficiency, reduced procedure times, and enhanced patient outcomes, with a preference for transparent and predictable pricing structures.
The physician always retains ultimate responsibility for diagnostic decisions and patient care, as AI tools like EndoNaut are designed to assist, not replace, human judgment. Manufacturers are responsible for the device's performance within its validated parameters and adherence to regulatory standards.
Successful AI deployment requires comprehensive training for staff and physicians to ensure effective utilization and understanding of the technology. Vendors typically provide training modules, technical support, and regular software updates to facilitate seamless integration and optimize performance in clinical workflows.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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