AMRA-MEDICAL
29.8.2024 15:56:33 CEST | Business Wire | Press release
AMRA Medical, a leading force in the development of MRI-based body composition analyses and biomarkers, is pleased to announce their EU Medical Device Regulation (MDR) certificate for the cutting-edge AMRA® Profiler 4 body composition analysis device.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240829196647/en/
AMRA® Profiler 4 provides rapid and precise body composition measurements in relation to normative data, contextualizing insights at the individual patient level, with high accuracy. (Graphic: Business Wire)
The 2017/745 (EU) MDR outlines the European regulations for medical devices and contains requirements, e.g., on the production, distribution, evaluation, and surveillance of medical devices. Manufacturers of medical devices must ensure compliance to MDR prior to bringing a medical device to the EU market. These requirements ensure that a medical device placed on the European market is both safe and effective for use by patients and providers.
The certificate comes as a successor to AMRA® Profiler 4’s 510(k) clearance by the US Food and Drug Administration (FDA), comfortably meeting the high standards for both EU and US markets in the push for increased use of AMRA’s cutting-edge body composition analysis methodologies in the clinic. Now that AMRA® Profiler 4 is CE marked, the device’s conformity with European MDR General Safety and Performance Requirements is clear. AMRA consistently demonstrates robust scientific methods and maturity in product development as they continue to take key steps in clinically translating their exciting MRI-based technologies.
AMRA® Profiler 4 provides clinicians with fat distribution, e.g., liver fat, and muscle composition biomarkers that comprise a detailed body composition profile to assist in diagnosis. Implemented right at the clinic, AMRA® Profiler 4 provides rapid and precise body composition measurements in relation to normative data, contextualizing insights at the individual patient level, with high accuracy. The AMRA biomarkers underlying this technology have proven to be useful in metabolic disease research efforts using the AMRA® Researcher service, and AMRA® Profiler 4’s recent MDR certification brings these powerful and unique biomarkers one step closer to patients everywhere.
Currently, AMRA® Profiler 4 is fully available through AMRA’s service provision in the UK, US, and Canada - with plans to roll out the product in the EU in the future following this MDR certificate milestone. If you or your organization are based in the currently cleared markets and would like to know more about bringing AMRA® Profiler 4 to your clinic, please contact info@amramedical.com.
You can learn how AMRA is using MRI-based fat distribution and muscle composition assessments to advance both research and clinical care by visiting our website, or get in touch with our knowledgeable scientists at info@amramedical.com to learn more about what AMRA can do for your trials, or for your patients.
About AMRA Medical
AMRA Medical is a health informatics and precision medicine company that is pioneering body composition analysis, providing cutting-edge solutions to advance both clinical research and patient care initiatives. AMRA's gold-standard technology delivers multiple fat and muscle biomarkers - derived simply from rapid whole-body MRI scans. AMRA is committed to driving transformative care and simplifying vital decision-making in both research and clinical care settings by offering services via their innovative platform.
Learn more about AMRA Medical’s MRI-based solutions at https://amramedical.com/solutions, or connect with our team of experts for a detailed discussion at info@amramedical.com.
Follow AMRA on LinkedIn for the latest updates in fat distribution and muscle composition assessments in disease research and precision medicine.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240829196647/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Menicon’s Largest Malaysia Plant Begins Commercial Production5.2.2026 10:00:00 CET | Press release
- Strengthening Global Production Capacity for the Rapidly Growing 1-Day Lens Market Menicon Co., Ltd. is pleased to announce that its new manufacturing facility in Kedah, Malaysia, has commenced commercial production. The plant strengthens Menicon’s long-standing commitment to technological excellence, uncompromising quality, and a stable global supply of contact lenses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127294120/en/ The newly opened Malaysia plant is Menicon’s largest site to date and is dedicated exclusively to producing 1-DAY lenses. As global demand for 1-DAY lenses continues rising and the industry faces widespread supply constraints, Menicon has made significant capital investments to expand production capacity—even amid the uncertainties presented by the COVID-19 pandemic. Construction of phase 1, currently underway, will provide capacity for up to 500 million lenses per year. The construction plan i
Ryan Expands UK Business Rates and Property Tax Capabilities with Acquisition of WYM Rating5.2.2026 09:00:00 CET | Press release
Ryan, a leading global tax services and software provider, is pleased to announce the acquisition of Williams Young McKaig Ltd, a specialized commercial property consultancy, and its specialist rating division, WYM Rating, based in Edinburgh. The acquisition establishes Ryan’s property tax and business rates presence in Scotland and expands the Firm’s ability to serve clients with complex commercial property portfolios across the United Kingdom. Founded in 2012 by Richard Williams, Don Young, and Billy McKaig, WYM Rating is recognized for its client-centered approach and deep expertise across commercial property advisory. The consultancy supports landlords, occupiers, and investors through practical, market-informed advice grounded in decades of hands-on experience. WYM Rating’s capabilities span three focus areas, closely aligning with Ryan’s capabilities: Business rates and property tax Commercial property advisory Occupier and lease advisory “WYM Rating brings exactly the kind of sp
Fujirebio and Sysmex Begin Sales Collaboration for Dementia Testing5.2.2026 07:30:00 CET | Press release
Fujirebio Holdings, Inc. (HQ: Minato-ku, Tokyo; President & CEO: Goki Ishikawa; “Fujirebio”), a consolidated subsidiary of H.U. Group Holdings, Inc. (HQ: Minato-ku, Tokyo; Chairman, President and Group CEO: Shigekazu Takeuchi) and Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano, “Sysmex”) have agreed on a sales collaboration for dementia testing. This agreement follows continued discussions based on the Basic Agreement on Business Collaboration in the Field of Immunoassay concluded in October 2023.1 Sysmex will exclusively sell Fujirebio's fully automated Lumipulse® immunoassay systems and dementia-related reagents ("the Products") in regions and countries mutually agreed upon by both companies. Going forward, Fujirebio and Sysmex will collaborate to meet the growing testing needs accompanying the wider adoption of therapeutic drugs and will gradually expand the countries where the Products are sold. Since entering into the Basic Agreement on Business Collaboration in Octob
Invivoscribe® Launches LeukoStrat® KMT2A + MRD Assay to Advance High-Sensitivity Leukemia Testing in Clinical Trials and Patient Management Worldwide5.2.2026 06:30:00 CET | Press release
Invivoscribe, a leader in precision medicine and measurable residual disease (MRD) testing, today announced the addition of the LeukoStrat®KMT2A + MRD Assay and Software to its industry-leading oncology portfolio. The assay leverages digital PCR (dPCR) to support both screening and precise longitudinal MRD monitoring for KMT2A rearrangements in acute myeloid leukemia (AML) subjects. This quantitative test is currently available for research use in clinical trials and as a stand-alone kit for purchase by our global customers, and will soon be available as a service in our regional LabPMM® laboratories worldwide. The assay is available to detect key AML-associated KMT2A rearrangements, which account for the vast majority of KMT2A fusion partners in AML1 and those most commonly targeted in menin-inhibitor clinical development programs. Later this year, the assay will be enhanced with four additional KMT2A rearrangements which are frequently found in acute lymphocytic leukemia (ALL), expan
VeriSilicon Enhanced ISP8200-FS Series IP Achieves ASIL B Functional Safety Certification5.2.2026 01:00:00 CET | Press release
Enabling Next-Generation High-Performance Automotive Camera Systems VeriSilicon (688521.SH) today announced its latest enhanced versions of Image Signal Processing (ISP) IP ISP8200-FS series, ISP8200-ES and ISP8200L-ES, featuring improved performance and energy efficiency to better support complex automotive camera systems. These enhanced IPs have successfully achieved ISO 26262 ASIL B functional safety certifications issued by TÜV NORD, an international inspection and certification institution, further validating their suitability and reliability for ADAS and autonomous driving applications. The latest enhanced ISP8200-FS series IP can operate at up to 1.2 GHz and support data processing from up to 16 image sensors. It significantly improves the performance of multi-camera scheduling, enabling flexible data-access capabilities and efficient hardware pipeline utilization for automotive camera systems. The enhanced series IP integrates image processing technologies including Color Noise
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom