{"product_name":"1CMR Pro","company_name":"Mycardium AI Limited","product_url":"https://mycardium.ai","company_url":"https://mycardium.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0129","summary":"1CMR Pro is an AI-driven software that enhances cardiovascular MRI analysis, improving diagnostic precision and efficiency for clinicians.","description":"1CMR Pro is an AI-powered software developed by MyCardium AI Limited, designed to automate the analysis of cardiovascular MRI images. It provides clinicians with precise insights into cardiac structure, function, and blood flow, facilitating faster and more accurate diagnoses. The software is compatible with 1.5T and 3T CMR scanners from major vendors, including Siemens, Philips, and GE, ensuring seamless integration into existing clinical workflows. 1CMR Pro has received FDA 510(k) clearance and CE Class IIb approval, underscoring its safety and efficacy in clinical settings. Additionally, it is ISO 13485 accredited, reflecting adherence to international quality standards in medical device development. The software offers features such as AI-based quantification of cardiac parameters, customizable viewing options, and cloud integration for secure data sharing and remote access. It is developed by clinicians for clinicians, emphasizing user-friendly design and advanced AI capabilities to support enhanced patient care.","categories":["clinical Care","diagnostic Support","administrative Operations","Clinical","Diagnostic","Administrative"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","cardiologists","medical imaging professionals"],"specialties":["Cardiology","Radiology","Medical Imaging"],"regions_available":["United States","European Union","United Kingdom"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United Kingdom"],"company_founding":"2022","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["AI-driven post-processing analysis for cardiovascular MRI","Automated contouring of cardiac structures","Quantification of key cardiac parameters (e.g., LV mass, stroke volume, ejection fraction)","Multi-slice, multi-phase, multi-parametric, and velocity-encoded CMR image analysis","Intuitive tools for zooming, panning, contrast adjustments, and synchronized cine playback","Cloud integration for secure data sharing and remote access","Explainable AI with user-visible generated contours and manual editing capabilities","Universal compatibility with 1.5T and 3T CMR scanners from major vendors (Siemens, Philips, GE)","Dynamic cine image playback with user-controlled speed for detailed functional analysis","Customizable viewing options including zoom, pan, contrast adjustments, and linear image interpolation","Validated for superior accuracy and a 40% increase in precision over human performance","High-quality validation data across diverse patient demographics and pathologies","Developed by clinicians for clinicians to enhance real-world applicability","BSE/ASE compliant design for standardized imaging protocols","Comprehensive training and support including onboarding, tailored sessions, and dedicated support desk","Flexible deployment options with cloud-hosted and on-premises configurations","Integration with existing healthcare systems through standard protocols","User-friendly interface designed to streamline diagnostic workflow","Continuous improvement through feedback from clinical users"],"optional_modules":["Advanced reporting tools","Integration with additional imaging modalities","Enhanced data analytics features","Patient management system integration","Telemedicine support","Mobile application for remote access","Advanced visualization tools","Clinical decision support system","Research data export capabilities","Customizable user interface themes"],"integrations":["PACS","RIS","EHR","DICOM viewers","EMR systems","Siemens MRI scanners","Philips MRI scanners","GE MRI scanners"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":["1.5T or 3T CMR scanner","Compatible DICOM viewer","Cloud infrastructure for deployment"],"compliance":["HIPAA","GDPR","ISO 13485","FDA 510(k)","CE Class IIb","ISO 9001","ISO 12385"],"certifications":["FDA 510(k)","CE Class IIb","ISO 13485","ISO 9001","ISO 12385"],"security_features":["End-to-end encryption","Role-based access control (RBAC)","Audit logs","Data anonymization","Secure data sharing","Multi-factor authentication (MFA)","Regular security audits","Compliance with healthcare privacy regulations","Data residency options","Disaster recovery planning"],"privacy_features":["Data anonymization","Consent management","Data minimization","Secure data sharing","Compliance with healthcare privacy regulations","Data residency options","Disaster recovery planning","Regular security audits","Multi-factor authentication (MFA)","Role-based access control (RBAC)"],"data_residency":"EU-only, US/EU regions, BYO cloud region","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0129","slug":"1cmr-pro","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/1cmr-pro.json"}}