{"product_name":"FFRangio System","company_name":"CathWorks","product_url":"https://cath.works/cathworks-ffrangio/","company_url":"https://cath.works","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0569","summary":"The FFRangio System by CathWorks is a non-invasive, AI-driven tool that provides real-time physiological assessments of coronary artery disease using routine angiograms, eliminating the need for pressure wires and drug stimulation.","description":"The FFRangio System combines artificial intelligence and advanced computational science to obtain physiological information from routine angiograms, offering quick and reliable intraprocedural assessments of the entire coronary tree. It eliminates the need for invasive pressure wires, drugs, or guide catheters, reducing radiation exposure by approximately 20% compared to wire-based physiology. The system features an intuitive user interface, AI-assisted angiogram analysis, and seamless integration with cath lab equipment and PACS. It provides real-time FFRangio values at every point along the coronary tree, a simulated pullback curve to differentiate functional patterns of CAD, and an integrated sizing tool for non-invasive lesion measurements. The system has demonstrated high diagnostic accuracy and promising outcomes, with similar major adverse cardiovascular event rates at one year compared to wire-based FFR. It has received FDA 510(k) clearance and is approved under the European Union Medical Device Regulation (MDR) 2017/745. The fourth-generation application has been approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).","categories":["clinical Care","diagnostic Support","cardiology","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","medical Device","clinical Assessment Tools","Clinical","Diagnostic","Cardiology","Medical Imaging","Artificial Intelligence","Medical Device","Non-invasive","Cardiovascular Disease","Angiography","Physiological Assessment"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Cardiologists","Interventional Cardiologists","Medical Imaging Technologists","Hospital Administrators"],"specialties":["Cardiology","Interventional Cardiology","Medical Imaging","Vascular Medicine","Cardiovascular Surgery","Radiology","Emergency Medicine","Internal Medicine","Geriatrics","Family Medicine","Preventive Medicine","Sports Medicine","Pediatrics","Obstetrics And Gynecology","Endocrinology","Nephrology","Pulmonology","Hematology","Oncology","Rheumatology"],"regions_available":["United States","Europe","Japan","Asia","Middle East"],"languages_supported":["English","Japanese","German","French","Spanish","Italian","Dutch","Portuguese","Russian","Chinese","Arabic","Hindi","Bengali","Punjabi","Javanese","Korean","Vietnamese","Telugu","Marathi","Turkish"],"pricing_model":"Enterprise_Quote","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States","Israel","Japan","Germany","France","United Kingdom","India","China","South Korea","Brazil"],"company_founding":"2012","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Non-invasive FFR guidance","3D coronary tree reconstruction","Real-time FFR values","Simulated pullback curve","Lesion Impact assessment","Integrated sizing tool","Intuitive user interface","AI-assisted angiogram analysis","Functional assessment during angiography","Seamless integration with boom and PACS"],"optional_modules":["Lesion Impact feature"],"integrations":["Boom","PACS"],"data_standards":["FHIR","HL7 v2","DICOM"],"api_available":"unknown","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0569","slug":"ffrangio-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/ffrangio-system.json"}}