ANDI

JSON twin: https://www.healthaidb.com/software/andi.json

Company Name

Imeka

Product URL

https://imeka.ca/andi/

Company URL

https://imeka.ca/

Categories

• clinical Care
• diagnostic Support
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• medical Device
• Clinical
• Diagnostic
• Imaging
• Neuroimaging
• Artificial Intelligence

Summary

ANDI is a quantitative imaging software developed by Imeka that analyzes brain white matter microstructure using diffusion MRI and AI, aiding in the diagnosis and monitoring of neurodegenerative diseases.

Description

ANDI (Advanced Neuro Diagnostic Imaging) is a quantitative imaging software developed by Imeka, a neuroimaging company specializing in advanced brain imaging. The software utilizes diffusion MRI and artificial intelligence to map and analyze the microstructural properties of white matter in the brain. It generates detailed reports that assist medical professionals, including neurologists and radiologists, in diagnosing and monitoring conditions such as Alzheimer's disease, multiple sclerosis, and traumatic brain injuries. ANDI has received FDA 510(k) clearance, indicating its safety and effectiveness for clinical use in the United States. The software is designed to be compatible with standard MRI machines, requiring only a single-shell, 5–8-minute acquisition sequence, and operates in a secure cloud environment for automated reporting. Imeka collaborates with major MRI manufacturers and pharmaceutical companies to continuously develop and validate innovative biomarkers, enhancing clinical tools for brain disease management.

Api Available

yes

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 9001
• ISO 13485
• ISO 14001
• ISO 45001
• ISO 50001
• ISO 55001
• ISO 56002
• ISO 56003
• ISO 56004
• ISO 56005
• ISO 56006
• ISO 56007
• ISO 56008
• ISO 56009
• ISO 56010
• ISO 56011
• ISO 56012

Company Founding

2011

Company Offices

• Canada
• United States
• Europe

Compliance

• HIPAA
• PIPEDA
• PHIPA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• ISO 27018
• ISO 27032
• ISO 27035
• ISO 27701
• ISO 22301
• ISO 22313
• ISO 22320
• ISO 22324
• ISO 22325
• ISO 22326
• ISO 22327
• ISO 22328
• ISO 22329

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10
• LOINC
• CPT
• ICD-9
• HL7 CDA
• HL7 CCD

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Multilingual support
• Privacy-first framework
• Explainable AI
• Symptom checking
• Medication suggestions
• Appointment scheduling
• Model Context Protocol (MCP) orchestration
• Privacy and Compliance Layer
• Role-based access control (RBAC)
• AES-GCM field-level encryption
• Tamper-evident audit logging
• HIPAA compliance
• PIPEDA compliance
• PHIPA compliance
• Multilingual patient-doctor interaction
• Transparent diagnostic reasoning
• Large language model integration

Id

SW0329

Integration Partners

Integrations

• EHR systems
• PACS
• Billing systems
• Laboratory information systems
• Pharmacy management systems
• Clinical decision support systems
• Patient portals
• Telemedicine platforms
• Wearable devices
• Health information exchanges
• Medical imaging devices
• Laboratory equipment
• Patient monitoring devices
• Clinical trial management systems
• Health data analytics platforms
• Population health management tools
• Medical coding systems
• Appointment scheduling systems
• Patient engagement platforms
• Clinical workflow management tools

Languages Supported

• English
• French

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Advanced analytics
• Predictive modeling
• Clinical decision support
• Patient engagement tools
• Telemedicine integration
• EHR integration
• Data visualization
• Reporting tools
• Mobile health monitoring
• Remote patient monitoring

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data masking
• Data tokenization
• Data pseudonymization
• Data retention policies
• Data access controls
• Data breach notification procedures

Product Code

SW0329

Product Name

ANDI

Ratings

Regions Available

• United States
• Canada
• Europe

Related Urls

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

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP
• Zero trust architecture
• Endpoint security
• Network segmentation
• Intrusion detection systems

Specialties

• Neurology
• Radiology
• Neurodegenerative Diseases
• Traumatic Brain Injury
• Multiple Sclerosis
• Alzheimer's Disease

Support Channels

System Requirements

Major OS/DB/hardware needs, or empty if SaaS-only

Target Users

• clinicians
• neurologists
• radiologists
• medical professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "ANDI",
  "company_name": "Imeka",
  "product_url": "https://imeka.ca/andi/",
  "company_url": "https://imeka.ca/",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0329",
  "summary": "ANDI is a quantitative imaging software developed by Imeka that analyzes brain white matter microstructure using diffusion MRI and AI, aiding in the diagnosis and monitoring of neurodegenerative diseases.",
  "description": "ANDI (Advanced Neuro Diagnostic Imaging) is a quantitative imaging software developed by Imeka, a neuroimaging company specializing in advanced brain imaging. The software utilizes diffusion MRI and artificial intelligence to map and analyze the microstructural properties of white matter in the brain. It generates detailed reports that assist medical professionals, including neurologists and radiologists, in diagnosing and monitoring conditions such as Alzheimer's disease, multiple sclerosis, and traumatic brain injuries. ANDI has received FDA 510(k) clearance, indicating its safety and effectiveness for clinical use in the United States. The software is designed to be compatible with standard MRI machines, requiring only a single-shell, 5–8-minute acquisition sequence, and operates in a secure cloud environment for automated reporting. Imeka collaborates with major MRI manufacturers and pharmaceutical companies to continuously develop and validate innovative biomarkers, enhancing clinical tools for brain disease management.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "imaging Software",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "medical Device",
    "Clinical",
    "Diagnostic",
    "Imaging",
    "Neuroimaging",
    "Artificial Intelligence",
    "Medical Device"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "neurologists",
    "radiologists",
    "medical professionals"
  ],
  "specialties": [
    "Neurology",
    "Radiology",
    "Neurodegenerative Diseases",
    "Traumatic Brain Injury",
    "Multiple Sclerosis",
    "Alzheimer's Disease"
  ],
  "regions_available": [
    "United States",
    "Canada",
    "Europe"
  ],
  "languages_supported": [
    "English",
    "French"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "Canada",
    "United States",
    "Europe"
  ],
  "company_founding": "2011",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Multilingual support",
    "Privacy-first framework",
    "Explainable AI",
    "Symptom checking",
    "Medication suggestions",
    "Appointment scheduling",
    "Model Context Protocol (MCP) orchestration",
    "Privacy and Compliance Layer",
    "Role-based access control (RBAC)",
    "AES-GCM field-level encryption",
    "Tamper-evident audit logging",
    "HIPAA compliance",
    "PIPEDA compliance",
    "PHIPA compliance",
    "Multilingual patient-doctor interaction",
    "Transparent diagnostic reasoning",
    "Large language model integration"
  ],
  "optional_modules": [
    "Advanced analytics",
    "Predictive modeling",
    "Clinical decision support",
    "Patient engagement tools",
    "Telemedicine integration",
    "EHR integration",
    "Data visualization",
    "Reporting tools",
    "Mobile health monitoring",
    "Remote patient monitoring"
  ],
  "integrations": [
    "EHR systems",
    "PACS",
    "Billing systems",
    "Laboratory information systems",
    "Pharmacy management systems",
    "Clinical decision support systems",
    "Patient portals",
    "Telemedicine platforms",
    "Wearable devices",
    "Health information exchanges",
    "Medical imaging devices",
    "Laboratory equipment",
    "Patient monitoring devices",
    "Clinical trial management systems",
    "Health data analytics platforms",
    "Population health management tools",
    "Medical coding systems",
    "Appointment scheduling systems",
    "Patient engagement platforms",
    "Clinical workflow management tools"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "HL7 CDA",
    "HL7 CCD"
  ],
  "api_available": "yes",
  "system_requirements": "Major OS/DB/hardware needs, or empty if SaaS-only",
  "compliance": [
    "HIPAA",
    "PIPEDA",
    "PHIPA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "ISO 27018",
    "ISO 27032",
    "ISO 27035",
    "ISO 27701",
    "ISO 22301",
    "ISO 22313",
    "ISO 22320",
    "ISO 22324",
    "ISO 22325",
    "ISO 22326",
    "ISO 22327",
    "ISO 22328",
    "ISO 22329"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 9001",
    "ISO 13485",
    "ISO 14001",
    "ISO 45001",
    "ISO 50001",
    "ISO 55001",
    "ISO 56002",
    "ISO 56003",
    "ISO 56004",
    "ISO 56005",
    "ISO 56006",
    "ISO 56007",
    "ISO 56008",
    "ISO 56009",
    "ISO 56010",
    "ISO 56011",
    "ISO 56012"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Zero trust architecture",
    "Endpoint security",
    "Network segmentation",
    "Intrusion detection systems"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data masking",
    "Data tokenization",
    "Data pseudonymization",
    "Data retention policies",
    "Data access controls",
    "Data breach notification procedures"
  ],
  "data_residency": "US/EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0329",
  "slug": "andi",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/andi.json"
  }
}