{"product_name":"EchoGo Pro","company_name":"Ultromics","product_url":"https://www.ultromics.com/products/echogo-pro","company_url":"https://www.ultromics.com","related_urls":["https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240860.pdf","https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0484","summary":"EchoGo Pro is an AI-powered decision support tool that assists clinicians in diagnosing coronary artery disease (CAD) by analyzing stress echocardiography images, enhancing diagnostic accuracy and patient outcomes.","description":"EchoGo Pro utilizes artificial intelligence to automate the analysis of stress echocardiography images, providing clinicians with a categorical assessment of the likelihood of significant CAD. This tool aims to reduce misdiagnoses and support early intervention, thereby improving patient care. It has been validated in the UK and US, demonstrating over 90% diagnostic performance (AUROC) and halving misdiagnoses compared to routine clinical practice. The FDA cleared EchoGo Pro in December 2020, marking it as the first AI-powered solution in echocardiography for CAD diagnosis.","categories":["clinical Decision Support","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","medical Device","Clinical Decision Support","Cardiovascular Imaging","Diagnostic Imaging","Artificial Intelligence","Medical Device"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Cardiologists","Radiologists","Healthcare Providers"],"specialties":["Cardiology"],"regions_available":["United States","United Kingdom","European Union"],"languages_supported":["English"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United Kingdom","United States"],"company_founding":"2017","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Automated echocardiography quantification (LV volumes, LVEF)","Automated global longitudinal strain measurement","Stress-echocardiography CAD detection","HFpEF detection and risk prediction","Cardiac amyloidosis detection module","AI-driven diagnostic decision support and risk scores","Vendor-neutral DICOM ingest and PACS connectivity","Automated report generation (cloud-based)","Batch processing / high-throughput analysis","Clinical analytics and outcomes reporting","Quality control and image triage assistance","Clinician user interface with visual overlays and measurements"],"optional_modules":["EchoGo Core (automated quantification)","EchoGo Amyloidosis","EchoGo Heart Failure (HFpEF detection)"],"integrations":["PACS (DICOM)","Hospital EHR / EMR systems (via integration)","RIS/reporting systems","DICOM modalities (ultrasound vendors)","Clinical workflow systems / reporting viewers","Microsoft Azure Marketplace","Johnson & Johnson Innovative Medicine","Pfizer","Mayo Clinic","Northwestern Medicine","University of Texas Southwestern","University of Chicago","Foundation for the NIH (FNIH)","NHS","Halo ITSM (support portal)"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"yes","system_requirements":"Modern web browser; cloud-hosted service (no on-prem server required for SaaS use)","compliance":["HIPAA","GDPR","UK Data Protection regulations"],"certifications":["FDA 510(k) clearance","CE mark","ISO 27001","ISO 13485"],"security_features":["Data encryption in transit and at rest","Role-based access control (RBAC)","SSO/SAML support","Audit logging","Multi-factor authentication (MFA/2FA)"],"privacy_features":["Business Associate Agreement (BAA) available","Patient data minimization and de-identification support for research"],"data_residency":"Cloud regions available (UK/EU and US cloud hosting options)","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0484","slug":"echogo-pro","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/echogo-pro.json"}}