{"product_name":"iCAC Device","company_name":"Bunkerhill","product_url":"https://bunkerhill.com","company_url":"https://bunkerhill.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0361","summary":"iCAC Device is an AI-powered software developed by Bunkerhill Health to detect and evaluate coronary artery calcification (CAC) in routine chest CT scans, aiding early cardiovascular risk assessment.","description":"iCAC Device utilizes advanced artificial intelligence algorithms to identify and quantify coronary artery calcification (CAC) in non-gated chest CT scans. By integrating seamlessly into existing clinical workflows, it enables healthcare providers to detect cardiovascular risks in asymptomatic patients, facilitating timely interventions and improved patient outcomes. The device has been FDA-cleared and is part of Bunkerhill Health's Careblocks platform, which automates care coordination and prioritizes patients for follow-up. It has been implemented in various health systems, including the University of Texas Medical Branch (UTMB), where it streamlined coronary calcium scoring and enhanced early detection capabilities. Additionally, Bunkerhill Health has partnered with Cleerly to further advance noninvasive cardiovascular care, combining their technologies to offer comprehensive solutions for coronary artery disease detection and risk assessment.","categories":["clinical Care","diagnostic Support","cardiology","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","Clinical","Diagnostic","Cardiology","Imaging","Artificial Intelligence"],"market_segment":["Enterprise","SMB"],"target_users":["Clinicians","Cardiologists","Radiologists","Healthcare Providers"],"specialties":["Cardiology","Radiology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["United States"],"company_founding":"2021","deployment_model":["SaaS"],"os_platforms":["Web"],"features":["Automated detection and quantification of aortic valve calcification from non-contrast chest CT scans","Integration with routine clinical workflows for early detection of aortic stenosis","Support for proactive disease management through early identification of calcific aortic valve disease (CAVD)"],"optional_modules":["Echocardiography recommendation system post-detection","Clinical decision support for cardiology and radiology specialists"],"integrations":["Clinical decision support systems","Electronic health record (EHR) systems","Picture archiving and communication systems (PACS)"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance for Bunkerhill AVC algorithm"],"security_features":["Data encryption","Role-based access control (RBAC)","Audit logs"],"privacy_features":["Business Associate Agreement (BAA) availability","Data anonymization","Data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0361","slug":"icac-device","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/icac-device.json"}}