AMRA-MEDICAL
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
Sinovac: Antigua Court Makes Interim Order Giving Board Control of the Company until the Trial of the Disputed 2025 Shareholder Meeting17.12.2025 13:00:00 CET | Press release
Sinovac Biotech Ltd. (NASDAQ: SVA) (SINOVAC or the Company), a leading provider of biopharmaceutical products in China, today announced that the Antigua High Court has ordered that the directors Mr. Simon Anderson, Mr. Shan Fu, Mr. Shuge Jiao, Mr. Yuk Lam Lo, Mr. Yumin Qiu, Mr. Yu Wang, Mr. Andrew Y. Yan and Mr. Yin Weidong (collectively, the Board), will comprise the Board of the Company until the trial listed in late April/early May 2026. The Antigua High Court decision arises from a hearing that took place on 27 October 2025, at which applicants SAIF Partners IV L.P., OrbiMed Partners Master Fund Limited and 1Globe Capital LLC each sought injunctions to confirm the composition of their respective favoured Boards, pending determination of a dispute over the outcome of the Company’s Special Shareholders Meeting on 8 July 2025 (the SSM Dispute). The hearing of the SSM Dispute has been scheduled to take place in the Antigua High Court in late April/early May 2026, with judgment to be de
Akamai and Visa Collaborate to Build Trust in Agentic Commerce17.12.2025 13:00:00 CET | Press release
Visa’s Trusted Agent Protocol to authenticate AI shopping agents and help prevent fraud across Akamai Cloud, strengthening the trust layer in agentic commerce Akamai Technologies, Inc. (NASDAQ: AKAM), the cybersecurity and cloud computing company that powers and protects business online, today announced a strategic collaboration with Visa (NYSE: V) to bring stronger identity, user recognition, and security controls to the emerging world of agentic commerce. Through its integration of Visa’s Trusted Agent Protocol with Akamai’s edge-based behavioral intelligence, user recognition, and bot and abuse protection, the companies will deliver the identity, authentication, and fraud controls required to let merchants confidently welcome AI agents with commerce intent into their digital storefronts. As autonomous AI agents increasingly browse, compare, and purchase on behalf of consumers, merchants face a new array of challenges. Merchants must now be able to differentiate this new type of legi
Mercans Launches the World’s First AI-Powered Globally Intelligent Workforce & Leave Management Engine17.12.2025 11:50:00 CET | Press release
A Unified Platform That Converts Unevaluated Time Data into Country- and Client-Compliant Workforce Transactions in Real Time Mercans, a global leader in payroll technology, workforce management, and HR SaaS solutions, today announced the launch of its next-generation Workforce Management (WFM) and Leave Management Engine - the world’s first platform capable of evaluating unevaluated time and attendance data against any country-specific legislation and client-specific policy framework, and converting it into fully evaluated, payroll-ready time transactions. This breakthrough engine fundamentally transforms how organizations manage time, attendance, and leave across borders by eliminating manual rule interpretation, fragmented systems, and country-by-country customizations. Solving a Global Workforce Challenge Traditional time and attendance systems capture raw or unevaluated data - clock-ins, clock-outs, absences, and leave requests - but fail to interpret that data in context. The res
EIG’s MidOcean Energy Completes Acquisition of Interest in Canada from PETRONAS17.12.2025 09:58:00 CET | Press release
MidOcean Energy (“MidOcean”), a liquefied natural gas (LNG) company formed and managed by EIG, a leading institutional investor in the global energy and infrastructure sectors, today announced the completion of its acquisition of a 20% interest in PETRONAS’ key entities in Canada. The transaction includes a 20% interest in the North Montney Upstream Joint Venture (“NMJV”), which holds PETRONAS’ upstream investment in Canada, and a 20% interest in the North Montney LNG Limited Partnership (“NMLLP”), which holds PETRONAS’ 25% participating interest in the LNG Canada Project. This strategic investment positions MidOcean across the LNG value chain, securing upstream resources and downstream liquefaction through the LNG Canada Project, with around 0.7 MTPA of associated LNG and potential to grow further. RBC Capital Markets acted as financial advisor to MidOcean, and Latham & Watkins acted as legal advisor. About EIG EIG is a leading institutional investor in the global energy and infrastru
Nexo Announces Landmark Crypto Partnership with Tennis Australia for Australian Open and Summer of Tennis17.12.2025 09:00:00 CET | Press release
Nexo has signed a landmark multi-year deal with Tennis Australia, covering the Australian Open and the Summer of Tennis. The partnership delivers exclusive experiences, including a feature in the Coachеs Pod. The announcement continues Nexo’s rapid global expansion, following three other major sports partnerships in 2025. Nexo, the premier digital assets platform, has entered a landmark multi-year global partnership with Tennis Australia, becoming the Official Crypto Partner of the Australian Open and the Summer of Tennis, including the United Cup, Adelaide International, Brisbane International, and Hobart International. This agreement marks the first time a digital asset company has partnered with a Grand Slam tournament, affirming Nexo’s prestige, long-term vision, and leadership at the intersection of elite sport and digital assets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251216497915/en/ Antoni Trenchev, Co-founde
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