{"product_name":"EchoMeasure","company_name":"iCardio.ai","product_url":"https://www.icardio.ai/echomeasure","company_url":"https://www.icardio.ai/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0143","summary":"EchoMeasure is an AI-powered software by iCardio.ai that automates echocardiographic interpretation, enhancing diagnostic efficiency and accuracy for clinicians.","description":"EchoMeasure utilizes machine learning algorithms to process DICOM-compliant cardiac ultrasound images, providing automated estimations of key cardiac measurements to support clinical decision-making in adult patients. It received FDA 510(k) clearance on October 10, 2024, marking a significant advancement in AI-driven cardiac imaging. The software is integrated into various distribution partners, including GE Healthcare, Viz.ai, UltraLinQ, and Butterfly Network, expanding its accessibility and utility in the healthcare sector.","categories":["clinical Care","diagnostic Support","cardiology","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","Clinical","Diagnostic","Cardiology","Medical Imaging","Artificial Intelligence"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Cardiologists","Healthcare Professionals"],"specialties":["Cardiology","Echocardiography","Medical Imaging"],"regions_available":["United States","Global"],"languages_supported":["English"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States"],"company_founding":"2019","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated echocardiography interpretation","Diastolic/systolic phase identification","Comprehensive anatomical measurement extraction","Automated echo report generation","Aortic stenosis detection from ultrasound clips","Image quality assessment with objective scoring","Integration with PACS systems","Customizable reporting templates","Multi-user access for clinicians and technicians","Cloud-based and on-premises deployment options","HIPAA/GDPR-compliant data storage and encryption","Web portal access for telecardiology consultations","Built-in quality control and accreditation-ready documentation","Detailed statistical reports for research and quality improvement"],"optional_modules":["Custom-tailored automated solutions","Data for clinical validation","Deployment of existing algorithms"],"integrations":["UltraLinQ PACS","Medtech Evolution PMS","Best Practice PMS","Zedmed PMS"],"data_standards":["DICOM","HL7 v2.x","FHIR R4"],"api_available":"yes","system_requirements":"Windows Server, Linux Server, PostgreSQL, Redis, AWS infrastructure","compliance":["HIPAA","GDPR","EU AI Act"],"certifications":["FDA 510(k) clearance","ISO 13485"],"security_features":["Encryption at rest (AES-256)","Encryption in transit (TLS 1.3)","Role-Based Access Control (RBAC)","Multi-Factor Authentication (MFA)","Audit logging","Data retention (7 years)"],"privacy_features":["Business Associate Agreement (BAA) available","Data anonymization","Data minimization","Consent management"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0143","slug":"echomeasure","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/echomeasure.json"}}