icobrain aria

JSON twin: https://www.healthaidb.com/software/icobrain-aria.json

Company Name

icometrix

Product URL

https://www.icometrix.com/disease/amyloid-related-imaging-abnormalities

Company URL

https://www.icometrix.com

Categories

• diagnostic Support
• clinical Care
• neurology
• imaging Software
• clinical Decision Support
• Diagnostic
• Clinical
• Ai-driven Imaging Analysis

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.

Api Available

yes

Certifications

• FDA clearance (icobrain aria)
• CE mark (NB1639)
• ISO 13485
• ISO 27001
• MDSAP

Company Founding

2011

Company Offices

• Belgium
• United States
• United Kingdom
• Netherlands
• Germany
• France
• Italy
• Spain
• Sweden
• Switzerland

Compliance

• FDA (cleared for icobrain aria)
• CE (NB1639)
• GDPR
• HIPAA (supports BAA)

Customers

Data Residency

Cloud hosting with region options (US and EU); on-prem hosting via icobridge for local data retention

Data Standards

• DICOM
• DICOM Structured Report (DICOM-SR)
• HL7 v2 (PDF report)

Deployment Model

• SaaS
• on_prem
• hybrid

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

Id

SW0134

Integration Partners

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

Languages Supported

• English
• Dutch
• French
• German
• Spanish
• Italian
• Japanese
• Hebrew
• Swedish
• Finnish
• Norwegian
• Danish
• Portuguese
• Russian
• Chinese
• Korean
• Arabic
• Turkish
• Polish
• Czech

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• icobridge on-prem appliance
• Extended reporting templates / custom templates
• Regulatory/security documentation pack (MDS2, CAIQ)
• Data processing / privacy agreement templates (DPA/BAA)

Os Platforms

• Web
• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA) template
• Data Processing Agreement (DPA) template
• Pseudonymization/anonymization
• Support for controller/processor model (customer as controller)

Product Code

SW0134

Product Name

icobrain aria

Ratings

Regions Available

• United States
• Europe
• Israel
• Japan
• Switzerland
• United Kingdom

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption in transit and at rest
• Pseudonymization
• Role-based access control (RBAC)
• Audit logs
• SSO/SAML support
• Secure on-prem gateway (icobridge)

Specialties

• Neurology
• Geriatrics
• Radiology

Support Channels

System Requirements

icobridge appliance (on-prem Linux-based gateway) or icometrix cloud; DICOM-capable scanners/PACS; hospital network connectivity

Target Users

• radiologists
• neurologists
• clinicians

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "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"
  }
}