{"product_name":"icobrain aria","company_name":"icometrix","product_url":"https://www.icometrix.com/disease/amyloid-related-imaging-abnormalities","company_url":"https://www.icometrix.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0134","summary":"icobrain aria is an AI-driven software developed by icometrix to detect, measure, and grade amyloid-related imaging abnormalities (ARIA) in Alzheimer's patients undergoing amyloid-targeting therapies.","description":"icobrain aria automates the detection and quantification of ARIA-E (edema/sulcal effusion) and ARIA-H (hemorrhage/superficial siderosis) in brain MRI scans, enhancing diagnostic accuracy and supporting safe treatment decisions for Alzheimer's disease patients. It has received FDA clearance and is approved in Europe, Israel, Japan, Switzerland, and the U.K.","categories":["diagnostic Support","clinical Care","neurology","imaging Software","clinical Decision Support","Diagnostic","Clinical","Neurology","Ai-driven Imaging Analysis"],"market_segment":["enterprise","smb"],"target_users":["radiologists","neurologists","clinicians"],"specialties":["Neurology","Geriatrics","Radiology"],"regions_available":["United States","Europe","Israel","Japan","Switzerland","United Kingdom"],"languages_supported":["English","Dutch","French","German","Spanish","Italian","Japanese","Hebrew","Swedish","Finnish","Norwegian","Danish","Portuguese","Russian","Chinese","Korean","Arabic","Turkish","Polish","Czech"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Belgium","United States","United Kingdom","Netherlands","Germany","France","Italy","Spain","Sweden","Switzerland"],"company_founding":"2011","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","Windows","Linux"],"features":["Automated detection and quantification of ARIA-E and ARIA-H on brain MRI","Voxel-wise/region volumetric quantification and segmentations","Color-coded segmentation overlays and visual annotations","Prepopulated radiology reporting templates","DICOM secondary capture and encapsulated PDF outputs","DICOM Structured Report and HL7 PDF report generation","Pseudonymization and encrypted data transfer"],"optional_modules":["icobridge on-prem appliance","Extended reporting templates / custom templates","Regulatory/security documentation pack (MDS2, CAIQ)","Data processing / privacy agreement templates (DPA/BAA)"],"integrations":["PACS","RIS","EMR/EHR","Epic","Cerner","Philips","Siemens Healthineers","GE Healthcare","Sectra","Agfa","Radiology viewers","Billing systems (for CPT processing)","Clinical registries / research platforms"],"data_standards":["DICOM","DICOM Structured Report (DICOM-SR)","HL7 v2 (PDF report)"],"api_available":"yes","system_requirements":"icobridge appliance (on-prem Linux-based gateway) or icometrix cloud; DICOM-capable scanners/PACS; hospital network connectivity","compliance":["FDA (cleared for icobrain aria)","CE (NB1639)","GDPR","HIPAA (supports BAA)"],"certifications":["FDA clearance (icobrain aria)","CE mark (NB1639)","ISO 13485","ISO 27001","MDSAP"],"security_features":["Encryption in transit and at rest","Pseudonymization","Role-based access control (RBAC)","Audit logs","SSO/SAML support","Secure on-prem gateway (icobridge)"],"privacy_features":["Business Associate Agreement (BAA) template","Data Processing Agreement (DPA) template","Pseudonymization/anonymization","Support for controller/processor model (customer as controller)"],"data_residency":"Cloud hosting with region options (US and EU); on-prem hosting via icobridge for local data retention","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0134","slug":"icobrain-aria","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/icobrain-aria.json"}}