{"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"}}