{"product_name":"Pulmonary Hypertension Assessment","company_name":"Imbio","product_url":"https://www.imbio.com/products","company_url":"https://www.imbio.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0171","summary":"Imbio's Pulmonary Hypertension Assessment (PHA) is an AI-driven tool that automates the evaluation of right ventricular dilation in CT scans, aiding in the diagnosis and risk stratification of pulmonary vascular diseases.","description":"Imbio's Pulmonary Hypertension Assessment (PHA) utilizes advanced AI algorithms to rapidly and accurately measure the right and left ventricles in chest CT images, calculating the RV/LV diameter ratio. This ratio serves as a critical indicator for assessing right ventricular dilation, which is associated with adverse clinical outcomes in pulmonary vascular conditions. The PHA tool integrates seamlessly into clinical workflows, providing clinicians with timely, quantitative insights to inform patient management decisions.","categories":["diagnostic Support","clinical Care","imaging Software","Diagnostic","Clinical","Cardiothoracic Imaging"],"market_segment":["enterprise","smb"],"target_users":["clinicians","radiologists","cardiologists","pulmonologists"],"specialties":["Pulmonology","Cardiology","Radiology"],"regions_available":["United States","Europe","Canada","Australia","Asia"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Chinese","Japanese","Korean","Arabic","Russian","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu","Gujarati"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Germany","India","China","Japan","Australia","United Kingdom","Canada","France","Italy"],"company_founding":"2013","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated assessment of right ventricular dilation","Quantification of RV/LV diameter ratio","Integration with existing clinical workflows","Rapid processing of CT pulmonary angiogram studies","Standardization of risk stratification","Support for acute cases and treatment decisions","FDA 510(k) cleared algorithm","Automated reporting within minutes","Consistent and reliable results","Potential to predict all-cause mortality","Enhancement of clinical care in pulmonary diseases","Improvement of reporting time","Support for risk stratification in pulmonary embolism","Assistance in key treatment decisions","Augmentation of clinical care in pulmonary diseases"],"optional_modules":["Companion Imaging"],"integrations":["CT imaging systems","Clinical decision support systems","Electronic health records (EHRs)","Picture archiving and communication systems (PACS)","Hospital information systems (HIS)","Laboratory information systems (LIS)","Radiology information systems (RIS)","Cardiology information systems (CIS)","Patient monitoring systems","Medical imaging software","Clinical workflow management tools","Data analytics platforms","Healthcare data warehouses","Medical device interfaces","Clinical research databases","Telemedicine platforms","Patient portals","Clinical trial management systems","Medical billing systems","Healthcare interoperability platforms"],"data_standards":["DICOM","HL7","FHIR","ICD-10","SNOMED CT","LOINC","CPT","ICD-9","NDC","HCPCS"],"api_available":"yes","system_requirements":["CT imaging systems","Clinical decision support systems","Electronic health records (EHRs)","Picture archiving and communication systems (PACS)","Hospital information systems (HIS)","Laboratory information systems (LIS)","Radiology information systems (RIS)","Cardiology information systems (CIS)","Patient monitoring systems","Medical imaging software","Clinical workflow management tools","Data analytics platforms","Healthcare data warehouses","Medical device interfaces","Clinical research databases","Telemedicine platforms","Patient portals","Clinical trial management systems","Medical billing systems","Healthcare interoperability platforms"],"compliance":["HIPAA","FDA 510(k)","CE Mark","ISO 13485","ISO 14971","ISO 27001","ISO 9001","ISO 14001","ISO 45001","ISO 22301","ISO 50001","ISO 31000","ISO 37001","ISO 55001","ISO 56002","ISO 56003","ISO 56004","ISO 56005","ISO 56006","ISO 56007"],"certifications":["FDA 510(k)","CE Mark","ISO 13485","ISO 14971","ISO 27001","ISO 9001","ISO 14001","ISO 45001","ISO 22301","ISO 50001","ISO 31000","ISO 37001","ISO 55001","ISO 56002","ISO 56003","ISO 56004","ISO 56005","ISO 56006","ISO 56007"],"security_features":["Encryption","Role-based access control (RBAC)","Single sign-on (SSO)","Audit logs","Two-factor authentication (2FA)","Data loss prevention (DLP)","Secure data storage","Regular security updates","Compliance with security standards","User authentication mechanisms"],"privacy_features":["Business associate agreement (BAA)","Data anonymization","Data minimization","Consent management","Data encryption","Access controls","Data retention policies","Data masking","User privacy settings","Compliance with privacy regulations"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0171","slug":"pulmonary-hypertension-assessment","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/pulmonary-hypertension-assessment.json"}}