AMRA Profiler

JSON twin: https://www.healthaidb.com/software/amra-profiler.json

Company Name

AMRA Medical

Product URL

https://amramedical.com/amra-receives-u-s-fda-clearance-for-amra-profiler-a-magnetic-resonance-diagnostic-software-application-enabling-non-invasive-evaluation-of-body-composition/

Company URL

https://amramedical.com

Categories

• diagnostic Support
• clinical Care
• imaging Software
• patient Monitoring
• Diagnostic
• Clinical
• Imaging
• Body Composition Analysis

Summary

AMRA Profiler is a diagnostic software that provides non-invasive, MRI-based body composition analysis, delivering precise measurements of fat and muscle distribution to assist in clinical assessments.

Description

AMRA Profiler is a diagnostic software application developed by AMRA Medical, utilizing magnetic resonance imaging (MRI) to non-invasively evaluate body composition. It generates 3D volumetric measurements of fat and muscle distribution, including visceral adipose tissue volume, subcutaneous adipose tissue volume, liver fat fraction, and thigh muscle volume. These measurements assist clinicians in diagnosing and monitoring metabolic diseases, muscle disorders, and other health conditions. The software is CE marked in Europe and FDA cleared in the United States, with availability in Sweden, Germany, the United Kingdom, the United States, and Canada. It is compatible with modern 1.5T and 3T MRI machines from GE, Siemens, and Philips, requiring no additional software installation at scanning facilities. The service operates on a per-use fee model, with pricing details available upon request. AMRA Medical, founded in 2010, is headquartered in Sweden and has offices in the United States and the United Kingdom.

Api Available

no

Certifications

• FDA 510(k)
• CE Marked
• EU MDR

Company Founding

2010

Company Offices

• Sweden
• United States
• United Kingdom

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001

Customers

Data Residency

US and EU regions

Data Standards

• DICOM 3.0

Deployment Model

• SaaS

Features

• Non-invasive body composition analysis
• 3D volumetric fat and muscle measurements
• Rapid whole-body MRI scan protocol
• Fat distribution assessment, including liver fat
• Muscle composition biomarkers
• Automated image analysis and segmentation
• Cloud-based processing and reporting
• Integration with GE Healthcare MRI systems
• CE marked for clinical use in Europe
• FDA cleared for clinical use in the US
• Available in Sweden, UK, Germany, US, and Canada

Id

SW0573

Integration Partners

Integrations

• GE Healthcare MRI systems

Languages Supported

• English
• Swedish
• German
• French
• Spanish
• Italian
• Dutch
• Portuguese
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Urdu
• Turkish
• Vietnamese
• Thai

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

Optional Modules

• AMRA® Researcher service for research purposes

Os Platforms

• Web

Pricing Details

Per-use fee; contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• BAA available
• Data minimization
• Consent management

Product Code

SW0573

Product Name

AMRA Profiler

Ratings

Regions Available

• Sweden
• Germany
• United Kingdom
• United States
• Canada

Related Urls

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

Release Year

Security Features

• Data anonymization
• Secure cloud storage
• Access controls

Specialties

• Metabolic Diseases
• Muscle Disorders
• Obesity
• Diabetes
• Cardiovascular Diseases
• Oncology
• Neurology
• Endocrinology
• Geriatrics
• Sports Medicine
• Orthopedics
• Pediatrics
• Gastroenterology
• Hepatology
• Pulmonology
• Rheumatology
• Infectious Diseases
• Immunology
• Dermatology
• Psychiatry

Support Channels

System Requirements

Compatible with modern 1.5T and 3T GE, Siemens, and Philips MRI machines

Target Users

• clinicians
• radiologists
• healthcare providers
• researchers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "AMRA Profiler",
  "company_name": "AMRA Medical",
  "product_url": "https://amramedical.com/amra-receives-u-s-fda-clearance-for-amra-profiler-a-magnetic-resonance-diagnostic-software-application-enabling-non-invasive-evaluation-of-body-composition/",
  "company_url": "https://amramedical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0573",
  "summary": "AMRA Profiler is a diagnostic software that provides non-invasive, MRI-based body composition analysis, delivering precise measurements of fat and muscle distribution to assist in clinical assessments.",
  "description": "AMRA Profiler is a diagnostic software application developed by AMRA Medical, utilizing magnetic resonance imaging (MRI) to non-invasively evaluate body composition. It generates 3D volumetric measurements of fat and muscle distribution, including visceral adipose tissue volume, subcutaneous adipose tissue volume, liver fat fraction, and thigh muscle volume. These measurements assist clinicians in diagnosing and monitoring metabolic diseases, muscle disorders, and other health conditions. The software is CE marked in Europe and FDA cleared in the United States, with availability in Sweden, Germany, the United Kingdom, the United States, and Canada. It is compatible with modern 1.5T and 3T MRI machines from GE, Siemens, and Philips, requiring no additional software installation at scanning facilities. The service operates on a per-use fee model, with pricing details available upon request. AMRA Medical, founded in 2010, is headquartered in Sweden and has offices in the United States and the United Kingdom.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "imaging Software",
    "patient Monitoring",
    "Diagnostic",
    "Clinical",
    "Imaging",
    "Body Composition Analysis"
  ],
  "market_segment": [
    "enterprise",
    "smb",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "radiologists",
    "healthcare providers",
    "researchers"
  ],
  "specialties": [
    "Metabolic Diseases",
    "Muscle Disorders",
    "Obesity",
    "Diabetes",
    "Cardiovascular Diseases",
    "Oncology",
    "Neurology",
    "Endocrinology",
    "Geriatrics",
    "Sports Medicine",
    "Orthopedics",
    "Pediatrics",
    "Gastroenterology",
    "Hepatology",
    "Pulmonology",
    "Rheumatology",
    "Infectious Diseases",
    "Immunology",
    "Dermatology",
    "Psychiatry"
  ],
  "regions_available": [
    "Sweden",
    "Germany",
    "United Kingdom",
    "United States",
    "Canada"
  ],
  "languages_supported": [
    "English",
    "Swedish",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Dutch",
    "Portuguese",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Urdu",
    "Turkish",
    "Vietnamese",
    "Thai"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Per-use fee; contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "Sweden",
    "United States",
    "United Kingdom"
  ],
  "company_founding": "2010",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Non-invasive body composition analysis",
    "3D volumetric fat and muscle measurements",
    "Rapid whole-body MRI scan protocol",
    "Fat distribution assessment, including liver fat",
    "Muscle composition biomarkers",
    "Automated image analysis and segmentation",
    "Cloud-based processing and reporting",
    "Integration with GE Healthcare MRI systems",
    "CE marked for clinical use in Europe",
    "FDA cleared for clinical use in the US",
    "Available in Sweden, UK, Germany, US, and Canada"
  ],
  "optional_modules": [
    "AMRA® Researcher service for research purposes"
  ],
  "integrations": [
    "GE Healthcare MRI systems"
  ],
  "data_standards": [
    "DICOM 3.0"
  ],
  "api_available": "no",
  "system_requirements": "Compatible with modern 1.5T and 3T GE, Siemens, and Philips MRI machines",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Marked",
    "EU MDR"
  ],
  "security_features": [
    "Data anonymization",
    "Secure cloud storage",
    "Access controls"
  ],
  "privacy_features": [
    "BAA available",
    "Data minimization",
    "Consent management"
  ],
  "data_residency": "US and EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0573",
  "slug": "amra-profiler",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/amra-profiler.json"
  }
}