{"product_name":"FFRangio","company_name":"CathWorks","product_url":"https://cath.works/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":"SW0528","summary":"FFRangio is a non-invasive system that provides real-time fractional flow reserve (FFR) assessments from routine angiograms, aiding in coronary artery disease diagnosis and treatment planning.","description":"FFRangio leverages artificial intelligence and advanced computational science to derive physiologic information from standard angiograms, eliminating the need for drug stimulation and invasive pressure wires. It offers quick and reliable intraprocedural FFR values for the entire coronary tree, enhancing clinical decision-making during percutaneous coronary interventions (PCI).","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","admins"],"specialties":["Cardiology"],"regions_available":["United States","Europe","Japan","Asia","Middle East"],"languages_supported":["English","Japanese"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States","Netherlands","Japan","Israel","China","India","South Korea","Singapore","Australia","United Kingdom"],"company_founding":"2014","deployment_model":["on_prem","hybrid"],"os_platforms":["Windows","macOS","Linux"],"features":["Non-invasive coronary artery disease assessment","Wire-free fractional flow reserve (FFR) measurement","Automated analysis of coronary angiograms","Real-time decision support for percutaneous coronary intervention (PCI)","Integration with existing cath lab equipment","User-friendly interface for clinicians","Comprehensive reporting capabilities","Clinical workflow optimization","Enhanced patient safety through reduced procedure time","Regulatory approval in multiple regions"],"optional_modules":["Advanced analytics","Remote monitoring","Data visualization tools"],"integrations":["Cath lab imaging systems","Hospital information systems","Electronic health records (EHR)"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"High-performance computing hardware, compatible cath lab imaging systems","compliance":["HIPAA","ISO 13485","CE Mark","FDA 510(k)"],"certifications":["FDA 510(k)","CE Mark","ISO 13485","ISO 14971","ISO 27001"],"security_features":["Data encryption","Role-based access control (RBAC)","Audit logs","Secure data transmission"],"privacy_features":["Data anonymization","Patient consent management","Data minimization"],"data_residency":"US and EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0528","slug":"ffrangio","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/ffrangio.json"}}