cNeuro cMRI

JSON twin: https://www.healthaidb.com/software/cneuro-cmri.json

Company Name

Combinostics

Product URL

https://www.combinostics.com/cmri/

Company URL

https://www.combinostics.com

Categories

• imaging Software
• radiology
• neurology
• ai Clinical Documentation Integrity
• clinical Decision Support
• medical Device Software
• regulatory Compliance
• data Security
• Clinical Imaging
• Diagnostic Imaging
• Medical Imaging
• Artificial Intelligence
• Software As A Medical Device

Summary

cNeuro cMRI is an AI-driven software that automates brain MRI quantification, enhancing diagnostic accuracy and efficiency for radiologists and clinicians.

Description

cNeuro cMRI is a cloud-based AI software developed by Combinostics, designed to provide fully automated brain MRI quantification. It integrates with PACS systems, offering results that can be viewed directly within PACS or through the cNeuro browser-based viewer. The software analyzes T1 and FLAIR MRI images to quantify volumes of 133 cortical and subcortical regions, detect white-matter lesions, and assess disease-specific biomarkers. It also quantifies longitudinal changes in brain structure and lesions, facilitating early detection and monitoring of neurodegenerative diseases. The results are statistically compared to normative reference data adjusted for age, sex, and intracranial volume, presented in tabular form or as age-corrected and gender-corrected plots. Additionally, cNeuro cMRI provides interactive image review capabilities, allowing comparison of multiple timepoints and toggling overlays for easy assessment of segmentation results. The software is CE marked, FDA 510(k) cleared, and ANVISA approved, ensuring compliance with international regulatory standards. Data security is prioritized, with all data transfers using SSL encryption and stored data being anonymized and encrypted. cNeuro cMRI is intended for automatic labeling, quantification, and visualization of segmentable brain structures from MRI images, aiming to automate the manual process of identifying, labeling, and quantifying these structures. It is intended for use by medical professionals working with medical imaging in office-like environments. The software has been validated for accuracy and reproducibility with 1,350 participants, demonstrating its reliability in clinical settings.

Api Available

unknown

Certifications

• CE Class IIa
• FDA 510(k) Class II

Company Founding

2014

Company Offices

• Finland
• United States

Compliance

• HIPAA
• GDPR
• ISO 27001
• ISO 27017
• ISO 27018
• SOC 1
• SOC 2
• SOC 3
• NIS2

Customers

Data Residency

EU-only

Data Standards

• DICOM

Deployment Model

• cloud-based

Features

• Brain region quantification (133 regions)
• Computed MTA
• Disease-specific biomarkers
• GCA and Fazekas scales
• Report generation
• Vascular burden quantification

Id

SW0602

Integration Partners

Integrations

• PACS
• AI marketplace
• web-based platforms

Languages Supported

• English
• Finnish

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• cNeuro cDSI
• cNeuro cARIA
• cNeuro cPET

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• data anonymization
• data minimization
• business associate agreements

Product Code

SW0602

Product Name

cNeuro cMRI

Ratings

Regions Available

• Finland
• United States
• European Union
• Brazil

Related Urls

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

Release Year

Security Features

• encryption
• firewalls
• continuous monitoring
• multi-factor authentication
• regular vulnerability assessments
• security awareness training
• incident response procedures
• change management controls

Specialties

• Neurology
• Radiology
• Neurodegenerative Diseases
• Dementia
• Multiple Sclerosis
• Traumatic Brain Injury
• Epilepsy

Support Channels

System Requirements

Target Users

• radiologists
• neurologists
• clinicians
• medical imaging professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "cNeuro cMRI",
  "company_name": "Combinostics",
  "product_url": "https://www.combinostics.com/cmri/",
  "company_url": "https://www.combinostics.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0602",
  "summary": "cNeuro cMRI is an AI-driven software that automates brain MRI quantification, enhancing diagnostic accuracy and efficiency for radiologists and clinicians.",
  "description": "cNeuro cMRI is a cloud-based AI software developed by Combinostics, designed to provide fully automated brain MRI quantification. It integrates with PACS systems, offering results that can be viewed directly within PACS or through the cNeuro browser-based viewer. The software analyzes T1 and FLAIR MRI images to quantify volumes of 133 cortical and subcortical regions, detect white-matter lesions, and assess disease-specific biomarkers. It also quantifies longitudinal changes in brain structure and lesions, facilitating early detection and monitoring of neurodegenerative diseases. The results are statistically compared to normative reference data adjusted for age, sex, and intracranial volume, presented in tabular form or as age-corrected and gender-corrected plots. Additionally, cNeuro cMRI provides interactive image review capabilities, allowing comparison of multiple timepoints and toggling overlays for easy assessment of segmentation results. The software is CE marked, FDA 510(k) cleared, and ANVISA approved, ensuring compliance with international regulatory standards. Data security is prioritized, with all data transfers using SSL encryption and stored data being anonymized and encrypted. cNeuro cMRI is intended for automatic labeling, quantification, and visualization of segmentable brain structures from MRI images, aiming to automate the manual process of identifying, labeling, and quantifying these structures. It is intended for use by medical professionals working with medical imaging in office-like environments. The software has been validated for accuracy and reproducibility with 1,350 participants, demonstrating its reliability in clinical settings.",
  "categories": [
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    "radiology",
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    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "medical Device Software",
    "regulatory Compliance",
    "data Security",
    "Clinical Imaging",
    "Diagnostic Imaging",
    "Radiology",
    "Neurology",
    "Medical Imaging",
    "Artificial Intelligence",
    "Software As A Medical Device",
    "Regulatory Compliance",
    "Data Security",
    "Medical Device Software"
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  "market_segment": [
    "enterprise",
    "smb"
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  "target_users": [
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    "neurologists",
    "clinicians",
    "medical imaging professionals"
  ],
  "specialties": [
    "Neurology",
    "Radiology",
    "Neurodegenerative Diseases",
    "Dementia",
    "Multiple Sclerosis",
    "Traumatic Brain Injury",
    "Epilepsy"
  ],
  "regions_available": [
    "Finland",
    "United States",
    "European Union",
    "Brazil"
  ],
  "languages_supported": [
    "English",
    "Finnish"
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  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "Finland",
    "United States"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "cloud-based"
  ],
  "os_platforms": [
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  ],
  "features": [
    "Brain region quantification (133 regions)",
    "Computed MTA",
    "Disease-specific biomarkers",
    "GCA and Fazekas scales",
    "Report generation",
    "Vascular burden quantification"
  ],
  "optional_modules": [
    "cNeuro cDSI",
    "cNeuro cARIA",
    "cNeuro cPET"
  ],
  "integrations": [
    "PACS",
    "AI marketplace",
    "web-based platforms"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
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    "GDPR",
    "ISO 27001",
    "ISO 27017",
    "ISO 27018",
    "SOC 1",
    "SOC 2",
    "SOC 3",
    "NIS2"
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  "certifications": [
    "CE Class IIa",
    "FDA 510(k) Class II"
  ],
  "security_features": [
    "encryption",
    "firewalls",
    "continuous monitoring",
    "multi-factor authentication",
    "regular vulnerability assessments",
    "security awareness training",
    "incident response procedures",
    "change management controls"
  ],
  "privacy_features": [
    "data anonymization",
    "data minimization",
    "business associate agreements"
  ],
  "data_residency": "EU-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0602",
  "slug": "cneuro-cmri",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/cneuro-cmri.json"
  }
}