{"product_name":"EndoNaut","company_name":"Therenva","product_url":"https://www.therenva.com/endonaut","company_url":"https://www.therenva.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0399","summary":"EndoNaut is an intraoperative navigation system that enhances endovascular procedures through advanced image fusion technology, reducing X-ray exposure and contrast media usage.","description":"EndoNaut offers a patented solution for intraoperative 3D navigation and device localization during endovascular procedures. It integrates seamlessly with any mobile or fixed C-arm, providing surgeons with precise visualization and control directly from the operating table via a smart touchscreen. The system is clinically validated, demonstrating significant reductions in X-ray dose and contrast media usage during aortoiliac and peripheral artery disease treatments. EndoNaut is compatible with over 20 angio systems and is available in more than 50 markets worldwide. It has received FDA 510(k) clearance and the CE mark under the new Regulation (EU) 2017/745 (MDR).","categories":["clinical Care","diagnostic Support","patient Facing","administrative Operations","Clinical","Diagnostic","Patient-facing","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","admins"],"specialties":["Vascular Surgery","Interventional Radiology","Cardiology","Endovascular Surgery"],"regions_available":["United States","European Union","Canada","Australia","Japan","South Korea","Brazil","India","China","Russia","South Africa","Mexico","Argentina","Chile","Colombia","Peru","Egypt","Saudi Arabia","United Arab Emirates","Turkey","Israel"],"languages_supported":["English","French","German","Spanish","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Turkish","Hebrew","Hindi","Bengali","Punjabi","Urdu","Tamil","Telugu"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["France","United States","Germany","United Kingdom","Italy","Spain","Netherlands","Belgium","Switzerland","Canada"],"company_founding":"2009","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Intraoperative 3D navigation","Image fusion technology","AI-based image processing","Autonomous control via touchscreen","Radioprotection reducing X-ray dose","Radioprotection reducing contrast media usage","Compatibility with all C-arm systems","Seamless integration with PACS","User-friendly interface","Adaptability to various operating rooms"],"optional_modules":["EndoNaut Aorto-iliac module","EndoNaut Peripheral module"],"integrations":["PACS","C-arm systems"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"Compatible with all C-arm systems","compliance":["HIPAA","FDA 510(k)","CE marked (class IIb)"],"certifications":["FDA 510(k)","CE marked (class IIb)"],"security_features":["Encryption","Role-Based Access Control (RBAC)","Audit logs","2FA"],"privacy_features":["Data anonymization","Data minimization"],"data_residency":"On-premises or cloud-based hosting options","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0399","slug":"endonaut","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/endonaut.json"}}