{"product_name":"CINA-iPE","company_name":"Avicenna.AI","product_url":"https://avicenna.ai/solutions/incidental-findings/cina-ipe","company_url":"https://avicenna.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0244","summary":"CINA-iPE is an AI-powered tool developed by Avicenna.AI that detects incidental pulmonary embolism in routine CT scans, enhancing early diagnosis and patient outcomes.","description":"CINA-iPE is an AI-based solution designed to identify incidental pulmonary embolism (PE) in CT scans performed for other clinical indications. It integrates seamlessly into radiologists' workflows, automatically detecting lung blood clots and prioritizing cases for timely intervention. This tool is particularly beneficial in oncology patients, where incidental PE is a significant cause of mortality. CINA-iPE has been validated on 381 CT scans from 39 different scanner models, achieving excellent sensitivity and specificity. It received FDA clearance in March 2024 and is CE-marked, ensuring its safety and efficacy in clinical settings.","categories":["clinical Care","diagnostic Support","radiology","imaging Software","clinical Decision Support","Clinical","Diagnostic","Radiology","Emergency Imaging","Incidental Findings Detection"],"market_segment":["Enterprise","SMB"],"target_users":["Radiologists","Emergency Physicians","Oncologists","Healthcare Administrators"],"specialties":["Pulmonology","Oncology","Emergency Medicine","Radiology"],"regions_available":["United States","European Union","Canada","Australia","Japan","South Korea","Brazil","India","China","South Africa","Mexico","Russia","Argentina","Saudi Arabia","United Arab Emirates","Singapore","Malaysia","Thailand","Indonesia","Philippines"],"languages_supported":["English","French","German","Spanish","Italian","Portuguese","Dutch","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"Subscription","pricing_details":"Contact vendor for pricing information.","license":"Commercial","company_offices":["France","United States","Germany","United Kingdom","Canada","Australia","Japan","South Korea","Brazil","India"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Automated detection of incidental pulmonary embolism on CT/CTA","Case triage and prioritization (worklist reordering/flagging)","DICOM ingestion and processing (DICOM listener)","Inline visualization: overlays/heatmaps on images","Automated notifications/alerts to radiologists","Integration with PACS/RIS/VNA/worklist","Batch/continuous background processing","Study-level metadata analysis and prioritization","Reporting and performance/quality metrics","Audit logging and result export"],"optional_modules":[],"integrations":["Blackford Platform","TeraRecon","Contextflow","DeepC","Sectra","PACS","RIS","VNA","Radiology worklist"],"data_standards":["DICOM","HL7 v2","FHIR","IHE"],"api_available":"yes","system_requirements":"DICOM-compatible CT imaging source and PACS/RIS connectivity; network access for image transfer; vendor deployment (cloud or on-prem) specifics per customer","compliance":["HIPAA","GDPR","FDA 510(k)","CE mark","EU MDR 2017/745"],"certifications":["FDA 510(k)","CE mark","EU MDR 2017/745"],"security_features":["Encryption in transit and at rest","Role-based access control (RBAC)","Audit logging","SSO/SAML support (integration capable)","Secure network connectivity/VPN support"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US and EU cloud regions; on-prem deployment available","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0244","slug":"cina-ipe","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/cina-ipe.json"}}