{"product_name":"Cardio-HART","company_name":"Cardio-Phoenix","product_url":"https://www.cardiophoenix.com/cardio-hart","company_url":"https://www.cardiophoenix.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0571","summary":"Cardio-HART is an AI-powered diagnostic system developed by Cardio-Phoenix to assist primary care physicians in the early detection of heart diseases, providing echo-grade cardiac insights within minutes.","description":"Cardio-HART integrates AI with biosignal fusion to deliver rapid, non-invasive cardiac assessments, enabling primary care physicians to detect heart failure, valve disease, arrhythmias, and other critical cardiac conditions efficiently. The system has been clinically validated across over 15,000 patients, demonstrating high sensitivity and specificity for various cardiac conditions. It is CE-marked and FDA 510(k) cleared, ensuring compliance with international medical device standards. Cardio-Phoenix, founded in 2005, is headquartered in London, UK, and employs between 10 to 50 staff members. The company is ISO 13485:2016 certified, reflecting its commitment to quality in medical device development. Cardio-HART is available in multiple countries and supports several languages, catering to a diverse user base. The product is offered through a subscription-based pricing model, with specific details available upon request. The license terms are proprietary, ensuring exclusive use of the technology developed by Cardio-Phoenix.","categories":["clinical Care","diagnostic Support","patient Facing","cardiology","clinical Decision Support","Clinical","Diagnostic","Patient-facing","Cardiology","Ai-powered Diagnostics"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Nurses","Patients","Admins"],"specialties":["Cardiology","Heart Failure","Valvular Heart Disease","Arrhythmias"],"regions_available":["United States","European Union","United Kingdom","Canada","Australia","New Zealand","India","South Africa","Brazil","Mexico","Japan","South Korea","China","Singapore","Malaysia","Thailand","Indonesia","Philippines","Vietnam","Pakistan"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Swedish","Norwegian","Danish","Finnish","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Urdu"],"pricing_model":"subscription","pricing_details":"Contact vendor for specific pricing information.","license":"proprietary","company_offices":["United Kingdom","United States","Canada","Germany","France","Italy","Spain","Netherlands","Australia","India"],"company_founding":"2005","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["AI-powered diagnostic system","ECG, PCG, and MCG integration","Detection of heart failure, valve disease, arrhythmias, and structural abnormalities","Simpson Biplane levels of LVEF estimation","Severity information on Echo and ECG findings","Structured reports readable by any clinician","Reduction in inconclusive ECGs","Increase in confirmed diagnoses","High echo-agreement rate","Fewer echo referrals","Reduced echo waiting lists and clinical backlogs","Same-day triage and improved time to treatment","Earlier HF diagnosis","Faster treatment initiation","Reduced low-value diagnostics","Optimized out-patient pathways","Cost savings through optimized referrals"],"optional_modules":["QT interval assessment","QTc-CHART multi-factor normalization"],"integrations":["ECG devices","PCG devices","MCG devices","EHR systems","PACS systems"],"data_standards":["HL7","FHIR","DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","GDPR","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA"],"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":"SW0571","slug":"cardio-hart","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/cardio-hart.json"}}