AMRA Profiler
by AMRA Medical AB
· Based in Sweden →
— Pioneering fat and muscle analysis with proprietary MRI-based technologies.
Contact for quote
Regulatory Status Disclosed
Overview
AMRA Profiler, developed by AMRA Medical AB, is an AI-powered medical tool that analyzes MRI images to quantify and classify fat and muscle composition. It is designed for use in both clinical and research settings, providing detailed body composition insights beyond traditional measurements.
- What it does: AMRA Profiler utilizes a patented, automated method to analyze MRI data, providing precise measurements of fat distribution and muscle composition. It aims to offer a comprehensive understanding of metabolic and musculoskeletal health.
- Who it is for: This tool is intended for various medical specialties and care settings. In clinical practice, it can be used by physicians seeking detailed patient insights for personalized care. In research, it supports drug development teams and researchers by providing imaging biomarkers for clinical trials.
- How it fits a clinical or practice workflow: AMRA Profiler integrates into existing workflows by analyzing standard MRI scans. It provides clinicians with easy-to-understand, personalized reports on a patient’s fat and muscle composition. For researchers, it offers standardized, cloud-based workflows to generate actionable insights from trial data.
- Notable capabilities: Key capabilities include its ability to classify and quantify various fat and muscle groups with precision. It offers services like AMRA® BCP Scan for overall fat and muscle composition and AMRA® MAsS Scan for muscle quality assessment. The platform leverages a large reference database for comparative analysis.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Transforms MR-images into 3D-volumetric fat and muscle measurements
- Non-invasive fat and muscle evaluation
- Provides measurements like visceral fat, subcutaneous fat, liver fat fraction, thigh muscle volume, and muscle fat infiltration
- Cloud-based analysis service with automated segmentation, quantification, and quality control
- Standardized, rapid MRI protocols (e.g., 6-8 minute whole-body scan)
- Platform-agnostic across major 1.5T and 3T MR scanners (GE, Siemens, Philips)
- Delivers easy-to-understand and individualized patient reports
- Utilizes a massive reference database for fat and muscle composition (55,000+ measurements)
- CE-marked in the EU (NB 2862) and registered as Class I product in Canada
Use Cases
- Supporting clinical practice for informed treatment decisions
- Facilitating disease research and drug development (e.g., metabolic, musculoskeletal, wasting diseases)
- Assisting in the diagnosis and monitoring of conditions like NAFLD/NASH, type 2 diabetes, obesity, sarcopenia, and neuromuscular disorders
- Bolstering preventative healthcare and executive wellness programs
- Monitoring health and wellness, detecting subtle body composition changes over time
- Providing a more accurate assessment of health risk beyond traditional BMI
What Physicians Need to Know
Key Capabilities
AMRA Profiler utilizes MRI-based analysis to generate precise, 3D-volumetric fat and muscle biomarkers from rapid 6-minute whole-body MRI scans. It measures visceral adipose tissue, subcutaneous adipose tissue, liver fat fraction, and thigh muscle volume. The cloud-based service provides individualized, easy-to-understand insights and offers specialized protocols like AMRAu00ae MAsS Scan for muscle composition analysis.
Clinical Utility
Intended as a decision support tool, AMRA Profiler assists in the diagnosis and monitoring of metabolic diseases, muscle diseases, and metabolic components of various conditions. It offers insights beyond traditional BMI measurements, aiding clinicians in making more informed treatment decisions, particularly for liver, musculoskeletal, metabolic, and wasting diseases. It can also correlate with functional tests for sarcopenia and frailty.
Integration Options
As a cloud-based service, AMRA Profiler requires no software installation at the scanning facility, only the correct scanning protocol on the MRI machine. It is compatible with most GE, Siemens, and Philips MRI systems, with protocols factory-loaded on newer GE scanners and available via Siemens' app store. De-identified images are securely transferred to AMRA via InteleShare for analysis, and standard results are delivered as PDF reports to PACS systems.
Compliance Status
AMRA Profiler 4 is FDA 510(k) cleared for use in the USA (K211983) and CE-marked (NB 2862) and EU MDR certified in Europe. It is available for clinical use in Sweden, the UK, Germany, and registered as a Class I product under MDEL for Canada. Patient health information is protected through de-identification or anonymization before transmission.
User Experience
The service provides easy-to-understand, individualized patient reports that include specific body composition measurements compared against normative values and peers. Standard results are typically delivered within two business days, with expedited 24-hour options available. The cloud-based workflow is designed to minimize setup complexities for users.
Support Quality
AMRA Medical offers an expert Scientific Advisory Service for research clients. For clinical services, pricing, and new projects, Business Development representatives are available. Dedicated support is also provided for ongoing studies.
Implementation Complexity
Implementation is streamlined due to its cloud-based nature, eliminating the need for local software installation. The primary requirement is the installation of the correct scanning protocol on the existing MRI machine. Scan acquisition times are relatively short, with standard protocols taking approximately 8 minutes.
Evidence Base
AMRA Profiler's accuracy and precision are supported by internal and external independent validation studies. The technology leverages the world's largest reference database for fat and muscle composition, including data from the UK Biobank (over 54,000 quality-controlled datasets). Published studies demonstrate its feasibility and clinical utility, notably in patients with end-stage liver disease, and collaborations with pharmaceutical companies like Pfizer further support its research applications.
Physician Tip
AMRA Profiler offers a powerful, objective assessment of body composition beyond traditional metrics like BMI, providing granular insights into fat distribution and muscle quality. This can be invaluable for early detection, personalized risk stratification, and monitoring treatment response in metabolic, liver, and musculoskeletal diseases. Consider integrating this tool for patients where precise body composition phenotyping can guide interventions, such as those with suspected sarcopenia, fatty liver disease, or complex metabolic disorders. The rapid scan time and detailed reports can enhance patient engagement and education.
AMRA Profiler's cloud-based architecture and compatibility with major MRI vendors (GE, Siemens, Philips) simplify its integration into existing imaging workflows. The delivery of results directly to PACS systems as standard PDF reports ensures a smooth transition into clinical practice without requiring extensive IT infrastructure changes or local software management. Secure data transfer protocols are in place to protect patient information.
Details
| Category | Endocrinology & Metabolic AI, Radiology & Imaging AI |
| Pricing |
Contact for quote
|
| Deployment | Cloud-based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated AMRA Profiler 4 has received 510(k) clearance (K211983) from the U.S. FDA for non-invasive fat and muscle evaluation, enabling the generation, display, and review of MR-based body composition measurements. |
| Integrations | |
| EHR | Not specified |
| Specialties | Endocrinology, Gastroenterology, Radiology |
Ratings & Reviews
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Press & Coverage
AMRA Medical
AMRA Medical Secures European Medical Device Regulation Certificate (NB 2862) for AMRAu00ae Profiler 4, Highlighting Yet Another Regulatory Win
AMRA Medical announced it has secured the EU Medical Device Regulation (MDR) certificate for its AMRAu00ae Profiler 4 body composition analysis device, following its 510(k) clearance by the US FDA. This certification ensures the device meets high standards for safety and effectiveness in both EU and US markets.
2024-08
AMRA Medical
AMRAu00ae Profiler 4 Pilot Study Demonstrates Feasible Assessment of Muscle Composition in Liver Transplant Candidates
A pilot study published in Annals of Hepatology demonstrated the feasibility of using AMRAu00ae MAsS Scan, powered by AMRAu00ae Profiler 4, for muscle composition assessments in patients with end-stage liver disease. The study found that MRI-data used in AMRAu00ae MAsS Scan are safely obtainable and can be analyzed by AMRAu00ae Profiler 4, even in severely decompensated cases.
2024-10
AMRA Medical
AMRA Medical Launches AMRAu00ae Profiler 4 in Sweden and Germany, Kickstarting Availability Campaign of AMRAu00ae BCP Scan Service in the EU
AMRA Medical launched its AMRAu00ae BCP Scan service, powered by AMRAu00ae Profiler 4, in Sweden and Germany, marking its availability in EU markets. This launch follows the device's EU MDR certification in November 2023 and FDA 510(k) clearance in late 2021.
2025-05
PMC (PubMed Central)
Utilizing a novel MRI technique to identify adverse muscle composition in end-stage liver disease: A pilot study - PMC
This prospective feasibility study explored a novel MRI protocol and automated image analysis technique (AMRAu00ae MAsS Scan) in adult liver transplant candidates with end-stage liver disease. The study found the technique feasible and correlated thigh muscle composition with validated measures of frailty and sarcopenia.
2024-05
PMC (PubMed Central)
Body composition and muscle composition phenotypes in patients on waitlist and shortly after liver transplant u2013 results from a pilot study - PMC
This pilot study evaluated the feasibility of MRI-based body composition profiling in liver transplant candidates, describing waitlist body composition and assessing changes over time. The study utilized an 8-minute MRI to measure body composition, including thigh fat-free muscle volume and fat infiltration.
2024-10
Medical Device Network
AMRA Medical secures FDA clearance for MR diagnostic software
AMRA Medical received FDA clearance for its magnetic resonance (MR) diagnostic software application, AMRA Profiler, for body composition assessment. The device transforms MR images from a six-minute whole-body MRI scan into 3D-volumetric fat and muscle measurements.
2018-12
Applied Radiology
AMRA receives FDA clearance for MRI body composition measurement software
AMRA Medical obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AMRAu00ae Profiler software, which precisely measures fat volumes, fat fractions, and lean tissue volumes from MRI scans. The software is intended as a decision support tool for clinical practice.
2019-01
AuntMinnie
AMRA, GE partner on MR body measurement tool - AuntMinnie
AMRA Advanced MR Analytics and GE Healthcare announced a collaboration to market AMRA's Profiler protocol, a cloud-based body composition measurement tool. This agreement will make AMRA Profiler available on future GE MR systems.
2016-03
Videos
Product demos, reviews, and walkthroughs for AMRA Profiler.
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Frequently Asked Questions
AMRA Profiler integrates as a cloud-based service that analyzes images from a rapid, 6-minute MRI scan, requiring only the correct scanning protocol on the MRI machine without additional software installation at the facility. It is particularly beneficial for patients where detailed body composition, including visceral fat, subcutaneous fat, liver fat, and muscle volume, is crucial for diagnosis and treatment decisions, especially in metabolic and musculoskeletal health.
AMRA Profiler 4 is 510(k)-cleared by the U.S. FDA, CE-marked in the EU under MDR, and registered as a Class I product in Canada, ensuring its compliance with stringent medical device regulations. For data privacy, AMRA states that all personal health information is removed during the upload of images for analysis, and the service is HIPAA compliant.
AMRA Profiler provides precise volumetric measurements of fat and muscle, with its accuracy and precision validated through internal and external independent studies. However, as an AI-powered diagnostic device, clinical diagnosis should not be based solely on its reports, and its utility is as a decision support tool when interpreted by a trained physician.
AMRA Profiler offers a new global standard in body composition assessment by transforming rapid MRI scans into precise 3D-volumetric fat and muscle measurements, going beyond traditional methods like BMI or waist circumference that provide less detailed information. Unlike some conventional imaging analyses that focus on specific body parts, AMRA Profiler provides a whole-body assessment with individualized insights and comparisons to a large reference database.
The cost for AMRA Profiler services is dependent on factors such as the number of sites, scans, measurements, and delivery outputs, and does not include separate charges from the MRI facility. Its value proposition lies in providing detailed, cost-effective, and non-invasive body composition assessments from a single MRI scan, potentially leading to more informed treatment decisions and reducing the need for additional tests compared to less comprehensive diagnostic approaches.
AMRA Profiler supports clinical decision-making by providing physicians with detailed body composition assessments and images, which, when interpreted by a trained physician, can yield information to assist in diagnosis. While the reports are designed to be easy to understand and personalized, a trained clinician's expertise is essential for accurate interpretation and contextualizing the AI-generated insights within the global clinical context of the patient.
While the search results highlight that AI systems can perpetuate biases if training data is not representative, AMRA Medical emphasizes its robust scientific methods and validated technology. The company utilizes a large reference dataset with over 55,000 fat and muscle measurements, which contributes to the generalizability of its body composition profiling.
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| Last Verified: 2026-04-17 | First Added: 2026-04-17