{"product_name":"Cleerly ISCHEMIA","company_name":"Cleerly","product_url":"https://cleerlyhealth.com/ischemia","company_url":"https://cleerlyhealth.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0320","summary":"Cleerly ISCHEMIA is an AI-driven software that analyzes coronary CT angiography images to assess coronary artery disease and detect ischemia, aiding in personalized heart disease diagnosis and treatment planning.","description":"Cleerly ISCHEMIA is an FDA-cleared, machine learning-based decision support tool designed to evaluate coronary CT angiography (CCTA) images. It quantifies atherosclerosis, stenosis, and vascular morphology to determine the likelihood of ischemia in coronary vessels. Integrated with Cleerly LABS software, it provides comprehensive insights for clinicians to personalize heart disease management. The software is billable under the Category I CPT code 75580 and is available by prescription only.","categories":["clinical Decision Support","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","healthcare Software Solutions","Clinical Decision Support","Cardiovascular Imaging","Diagnostic Imaging","Artificial Intelligence","Medical Software"],"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":"2018","deployment_model":["SaaS","cloud-proxy (hybrid)"],"os_platforms":["Web"],"features":["AI-powered CCTA plaque quantification and characterization (LD-NCP, NCP, CP)","Stenosis measurement and vessel-level stenosis severity","Likelihood of vessel-specific ischemia (Cleerly ISCHEMIA)","3D coronary artery modeling (lumen and vessel wall segmentation)","Interactive web-based provider report and viewer","Serial CCTA comparison and disease progression tracking","Automated lesion-level measurements and summary report","Multiple delivery methods for results (email, DICOM PDF, DICOM SC, web portal)","CCTA upload options with processing workflow and status reporting","Processing performance metrics (average processing time, rejection rates)"],"optional_modules":["Cleerly ISCHEMIA (ischemia likelihood algorithm)","Cleerly Proxy (cloud-based connector/minimal onsite footprint)"],"integrations":["Nuance PowerShare","Intelerad Inteleshare","Cleerly Proxy (connectivity appliance/service)"],"data_standards":["DICOM","DICOM PDF"],"api_available":"unknown","system_requirements":"","compliance":["FDA-cleared"],"certifications":["FDA 510(k)"],"security_features":["Encryption","RBAC","SSO/SAML","audit logs","2FA","DLP"],"privacy_features":["BAA available","consent mgmt","anonymization","data minimization"],"data_residency":"US/EU regions","customers":["CrelioHealth LIMS","ARIA Oncology Information System","MOSAIQ Radiation Oncology","CARESTREAM Vue RIS","PacsCube","virtualPACS Gateway","MiNNOVAA PACS","Ambra Health"],"user_reviews":["Turns out Clari took the approach of every other self-proclaimed AI analytics company and opted to record data in a format that overwrites and/or deletes data they deemed 'negative results' to ensure their software highlights that their various useless tools are working."],"ratings":["4.7/5 (CrelioHealth LIMS)","4.1/5 (ARIA Oncology Information System)","3.3/5 (MOSAIQ Radiation Oncology)","4.4/5 (CARESTREAM Vue RIS)","4.5/5 (PacsCube)","4.4/5 (virtualPACS Gateway)","4.8/5 (MiNNOVAA PACS)","4.5/5 (Ambra Health)"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2025","integration_partners":["CrelioHealth LIMS","ARIA Oncology Information System","MOSAIQ Radiation Oncology","CARESTREAM Vue RIS","PacsCube","virtualPACS Gateway","MiNNOVAA PACS","Ambra Health"],"id":"SW0320","slug":"cleerly-ischemia","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/cleerly-ischemia.json"}}