{"product_name":"cmAngio","company_name":"CureMetrix","product_url":"https://curemetrix.com/cmangio","company_url":"https://curemetrix.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0046","summary":"cmAngio is an AI-driven software that detects Breast Arterial Calcifications (BAC) in mammograms, aiding radiologists in identifying potential cardiovascular risks without additional procedures or radiation.","description":"cmAngio is an FDA-cleared AI-based software developed by CureMetrix to detect and localize Breast Arterial Calcifications (BAC) in full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) screening mammograms. By analyzing existing mammograms, it enables radiologists to identify women with BAC and refer them for further evaluation, enhancing cardiovascular risk assessment without additional radiation or procedures. The software is compatible with both Hologic and GE Healthcare mammography platforms and is HIPAA-compliant and cybersecure. It installs quickly, in less than an hour, and is compatible with any DICOM-compliant viewer. cmAngio has demonstrated performance across all breast densities and has been validated on multiple imaging platforms, including Hologic and GE Healthcare. It is available for commercial use in the U.S. and has been registered as a medical device in Brazil. The software has been integrated into various healthcare networks, including SimonMed Imaging's 150 imaging centers, and is accessible to over 3,500 facilities through partnerships with Volpara Health and Lunit. Additionally, cmAngio has been integrated into the Blackford platform, expanding its reach to healthcare professionals seeking BAC detection solutions.","categories":["clinical Care","diagnostic Support","radiology","cardiology","Clinical","Diagnostic","Radiology","Cardiology"],"market_segment":["enterprise","smb"],"target_users":["radiologists","clinicians","healthcare providers"],"specialties":["Cardiology","Radiology"],"regions_available":["United States","Brazil"],"languages_supported":["English","Portuguese"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States","Brazil"],"company_founding":"2016","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["FDA-cleared AI-based detection software for Breast Arterial Calcifications (BAC)","Processes both FFDM and DBT mammogram exams","Adjustable operating point to meet clinical goals","Quick installation in less than an hour","Compatible with any DICOM-compliant viewer","Cybersecure and HIPAA-compliant","Demonstrated performance across all breast densities","Provides visualization of BAC location on cmAngio scorecard","Enables BAC identification and reporting without additional radiation","Allows integration into overall patient assessment and follow-up recommendations","Helps identify women with BAC who might otherwise remain undiagnosed"],"optional_modules":[],"integrations":["DICOM-compliant viewers"],"data_standards":["DICOM"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA"],"certifications":["FDA 510(k) Submission #K232367"],"security_features":["Cybersecurity measures","HIPAA compliance"],"privacy_features":["HIPAA compliance"],"data_residency":"US","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0046","slug":"cmangio","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/cmangio.json"}}