{"product_name":"EchoGo Amyloidosis","company_name":"Ultromics","product_url":"https://www.ultromics.com/echogo-amyloidosis","company_url":"https://www.ultromics.com","related_urls":["https://www.prnewswire.com/news-releases/ultromics-granted-fda-breakthrough-device-designation-for-ai-enhanced-cardiac-amyloidosis-detection-301808243.html","https://www.lightrock.com/portfolio/ultromics/","https://biotechscope.com/company/ultromics/","https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0130","summary":"EchoGo® Amyloidosis is an AI-driven diagnostic tool that analyzes echocardiograms to identify cardiac amyloidosis, aiding early detection and treatment decisions.","description":"EchoGo® Amyloidosis is an FDA-cleared, AI-based screening tool designed to detect cardiac amyloidosis from standard echocardiogram images. It integrates seamlessly into clinical workflows, analyzing data to identify at-risk patients and generate reports for interpreting physicians. The device has demonstrated high sensitivity and specificity in detecting cardiac amyloidosis, including various subtypes, and is eligible for Medicare reimbursement in both inpatient and outpatient settings.","categories":["diagnostic Support","clinical Care","cardiology","Diagnostic","Clinical","Cardiology"],"market_segment":["enterprise","smb"],"target_users":["clinicians","cardiologists","healthcare providers"],"specialties":["Cardiology"],"regions_available":["United States","United Kingdom","Europe","Canada","Australia","New Zealand","Japan","South Korea","Singapore","Hong Kong","India","China","Brazil","Mexico","South Africa","Saudi Arabia","United Arab Emirates","Israel","Turkey","Russia"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Swedish","Norwegian","Danish","Finnish","Polish","Czech","Hungarian","Romanian","Bulgarian","Greek","Turkish","Russian","Chinese","Japanese"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United Kingdom","United States","Germany","France","Italy","Spain","Netherlands","Sweden","Norway","Denmark"],"company_founding":"2017","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["AI-based cardiac amyloidosis detection from echocardiograms","Automated analysis of single apical 4-chamber echo video clips","Integration with existing clinical systems via DICOM","Automated report generation","Cloud-native architecture for scalability","Secure cloud VPN connection with data anonymization","FDA-cleared as a Breakthrough Device","Reimbursement support with NTAP and HCPCS codes"],"optional_modules":[],"integrations":["PACS","Hospital EHR/EMR systems","RIS/reporting systems","DICOM modalities (ultrasound vendors)","Clinical workflow systems/reporting viewers"],"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","ISO 27001","ISO 13485","SOC 2 Type II","CyberEssentials"],"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":["Data anonymization","Data residency options in UK/EU and US cloud hosting regions"],"data_residency":"UK/EU and US cloud hosting options","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0130","slug":"echogo-amyloidosis","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/echogo-amyloidosis.json"}}