{"product_name":"HeartFlow Plaque Analysis","company_name":"HeartFlow","product_url":"https://www.heartflow.com/plaque-new/","company_url":"https://www.heartflow.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0401","summary":"HeartFlow Plaque Analysis is an AI-powered tool that non-invasively quantifies and characterizes coronary artery plaque to aid in diagnosing and managing coronary artery disease (CAD).","description":"HeartFlow Plaque Analysis utilizes proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating personalized 3D models that quantify and characterize plaque volume in coronary arteries, assisting in CAD risk assessment. The platform integrates with FFR_{CT} values when performed, offering comprehensive insights for clinical decision-making and personalized patient treatment plans. It has received FDA 510(k) clearance and is covered by major insurers, including UnitedHealthcare and Cigna, enhancing its accessibility for patients and clinicians. ([ir.heartflow.com](https://ir.heartflow.com/news-releases/news-release-details/heartflow-announces-fda-510k-clearance-and-launch-next?utm_source=openai))","categories":["diagnostic Support","clinical Care","patient Facing","Diagnostic","Clinical","Patient-facing"],"market_segment":["enterprise","smb"],"target_users":["clinicians","patients"],"specialties":["Cardiology"],"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":"2014","deployment_model":["SaaS","cloud-based"],"os_platforms":["Web"],"features":["FFRCT (lesion-specific physiologic assessment)","3D patient-specific coronary anatomy reconstruction","Color-coded FFR values and interactive 3D viewer","Lesion localization and sequential lesion evaluation","Planner (treatment planning / virtual PCI planning)","Roadmap visualization of coronary lesions","Plaque analysis (plaque burden and composition)","Pins/measurements along coronary tree","Automated report generation","Rapid turnaround (median ~90 minutes)"],"optional_modules":["Plaque Analysis","FFRCT Analysis","Roadmap Analysis","Planner"],"integrations":["Epic","Cerner","PACS vendors","Hospital IT/enterprise imaging teams","Clinical research and registry partners"],"data_standards":["DICOM","HL7 v2","FHIR","IHE profiles","SNOMED","ICD-10"],"api_available":"yes","system_requirements":"","compliance":["HIPAA","GDPR","HITECH","HITRUST","ISO 27001","SOC 2"],"certifications":["FDA 510(k)","CE Mark","PMDA (Japan) approval","Health Canada medical device licensing"],"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":["Cigna Health Insurance"],"user_reviews":["HeartFlow's Plaque Analysis has significantly improved our diagnostic accuracy, leading to better patient outcomes.","The 3D visualization feature provides a clear understanding of plaque distribution, enhancing our treatment planning.","Integrating HeartFlow's platform into our workflow was seamless, and the support team was highly responsive.","The AI-driven insights have streamlined our decision-making process, making it more efficient.","HeartFlow's Plaque Analysis has become an indispensable tool in our cardiology department."],"ratings":["4.5 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))","4.4 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))","4.3 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))","4.1 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))","4.7 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))","4.8 out of 5 on G2 ([g2.com](https://www.g2.com/products/heartflow/competitors/alternatives?utm_source=openai))"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2025","integration_partners":["3D Slicer","Simpleware","Invivo5","OsiriX MD","Materialise Mimics Care Suite","D2P (DICOM to PRINT)","Axial3D | Medical 3D Printing","MiNNOVAA PACS"],"id":"SW0401","slug":"heartflow-plaque-analysis","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/heartflow-plaque-analysis.json"}}