JSON twin: https://www.healthaidb.com/software/icobrain-aria.json
icometrix
https://www.icometrix.com/amyloid-related-imaging-abnormalities
AI-powered MRI software that automatically detects, quantifies and grades amyloid-related imaging abnormalities (ARIA) to support monitoring of patients on anti-amyloid therapies for Alzheimer's disease.
icobrain aria is a clinically-validated, regulatory-cleared (FDA, CE) software-only tool from icometrix that analyses brain MRI to detect ARIA-E and ARIA-H, measure lesion extent, provide severity grading and structured reports to assist radiologists and treating clinicians in safety monitoring during amyloid-targeting therapy.
yes
2011
Cloud hosting with region options (US and EU); on‑prem hosting via icobridge for local data retention
P1979
2025-09-07
commercial proprietary
contact vendor (no public pricing; demo and commercial licensing available)
enterprise_quote
2024
icobridge appliance (on‑prem Linux-based gateway) or icometrix cloud; DICOM‑capable scanners/PACS; hospital network connectivity
product
1.0
{ "company_name": "icometrix", "company_url": "https://www.icometrix.com", "company_offices": [ "Belgium", "United States" ], "company_founding": "2011", "product_url": "https://www.icometrix.com/amyloid-related-imaging-abnormalities", "categories": [ "diagnostic", "clinical decision support", "medical imaging", "neurology", "AI-based software" ], "market_segment": [ "enterprise", "hospital", "research" ], "links": [ "https://www.icometrix.com/amyloid-related-imaging-abnormalities", "https://www.icometrix.com/about", "https://www.icometrix.com/contact", "https://www.icometrix.com/evidence", "https://healthairegister.com/products/icometrix-icobrain-aria", "https://pubmed.ncbi.nlm.nih.gov/38345816/", "https://www.neurology.org/doi/10.1212/WNL.0000000000206238", "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240712.pdf", "https://www.icometrix.com/post/market-approval-for-icobrain-aria" ], "summary": "AI-powered MRI software that automatically detects, quantifies and grades amyloid-related imaging abnormalities (ARIA) to support monitoring of patients on anti-amyloid therapies for Alzheimer's disease.", "description": "icobrain aria is a clinically-validated, regulatory-cleared (FDA, CE) software-only tool from icometrix that analyses brain MRI to detect ARIA-E and ARIA-H, measure lesion extent, provide severity grading and structured reports to assist radiologists and treating clinicians in safety monitoring during amyloid-targeting therapy.", "target_users": [ "radiologists", "neurologists", "neuroradiologists", "clinical radiology technologists", "clinical trial teams", "hospital administrators", "imaging centers" ], "specialties": [ "neurology", "neuroradiology", "dementia/Alzheimer's disease", "clinical trials monitoring" ], "regions_available": [ "United States", "European Union", "Belgium" ], "languages_supported": [ "English" ], "pricing_model": "enterprise_quote", "pricing_details": "contact vendor (no public pricing; demo and commercial licensing available)", "license": "commercial proprietary", "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", "icobridge on-prem gateway for local routing and decryption", "Cloud-based quality control and centralized processing", "Turnaround time measurement (minutes-level processing)", "Clinical decision support for amyloid-targeting therapy monitoring", "Interactive quantitative reports for longitudinal comparison", "Automated QC and algorithmic quality control", "Integration-ready workflow (scanner → PACS → icobridge → cloud → PACS/EMR)" ], "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", "Philips (strategic partnership / OEM integration)", "Local scanner/DICOM modalities", "Hospital network (ICObridge integration)", "Seqster (partnership for RWD integration)" ], "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": [ "FDA clearance (USA, 2024)", "CE mark / EU approval", "Market approvals reported for Japan, Israel, Switzerland, Turkey, United Kingdom" ], "support_channels": [], "training_options": [ "documentation", "webinars", "live_online" ], "release_year": "2024", "integration_partners": [ "Philips" ], "id": "P1979", "slug": "icobrain-aria", "type": "product", "version": "1.0", "last_updated": "2025-09-07", "links_json": { "self": "https://www.healthaidb.com/software/icobrain-aria.json" } }