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
Elegen and Nutcracker Therapeutics to Pilot First Fully Cell-Free Manufacturing Process for RNA-based Personalized Cancer Therapeutics11.7.2025 14:00:00 CEST | Press release
Fully cell-free process aims to further democratize personalized cancer therapeutic manufacturing with shorter turnaround times and negligible bioburden and endotoxin risks. Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufacturing, today announced the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711152688/en/ As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hi
$MBG Token Pre-Sale Set for July 15 — Only 7 Million Tokens Available at $0.3511.7.2025 10:17:00 CEST | Press release
MultiBank Group, the world’s largest financial derivatives institution headquartered in Dubai, has confirmed that its highly anticipated $MBG Token pre-sale will go live on July 15, with demand expected to be intense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711737311/en/ With only 7 million $MBG tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. With only 7 million tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. Early participants can join simultaneously on MultiBank.io, the Group’s regulated crypto exchange, and Uniswap, the world’s leading decentralized platform. Supported by $29 billion in real assets and powered by over $35 billion in daily turnover, $MBG is engineered
Live Story Raises €2.7 Million to Revolutionize the Digital Experience11.7.2025 10:05:00 CEST | Press release
With a round led by Vertis, the next-generation CMS platform accelerates its focus onAI, performance, and European expansion. Target: surpass €10M in recurring revenueby 2027. Live Story, the tech company founded by Stefano Mocellini, has closed a €2.7 million seed round led by Vertis, one of Italy’s leading early-growth venture capital firms. The funding will support the company’s international expansion and technological development, with a clear goal: to exceed €10 million in annual recurringrevenue by 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711335560/en/ “We invested in Live Story because it addresses one of the major inefficiencies in digital commerce: the slow and rigid management of visual and narrative content,” says Alessandro Pontari, Partner at Vertis SGR. “The platform helps brands drastically reduce their time-to-market through a visual CMS that integrates seamlessly with any tech stack. In a wor
With a Score of 84 out of 100, Sagemcom Is Awarded the EcoVadis Platinum Medal: a Prestigious Recognition of its CSR Commitment11.7.2025 09:00:00 CEST | Press release
Sagemcom Group is proud to announce that it has been awarded, for the third time, the Platinum Medal by EcoVadis, the highest distinction granted by the leading global platform for assessing Corporate Social Responsibility (CSR) performance. This medal places Sagemcom in the top 1% of companies evaluated worldwide, across all industries. With a score of 84 out of 100, Sagemcom reaffirms its position as a committed leader in ecological transition, business ethics, sustainable supply chain management, and social responsibility. “The EcoVadis Platinum Medal is more than just an award — it is the recognition of our collective efforts to embed sustainable development principles at the heart of our corporate strategy and culture,” says Sylvaine Couleur, Executive Vice President, CSR & Communication. “Achieving this level demonstrates that our commitments are tangible, impactful, and internationally recognized. This distinction strengthens our determination to further advance and expand our C
IEEE Standards Commitment to Advancing AI Governance Includes Impactful Contributions to New International AI Standards Exchange11.7.2025 08:00:00 CEST | Press release
IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and its IEEE Standards Association (IEEE SA) announced today that its portfolio of over 100 global AI-related standards is included in the new International AI Standards Exchange. This Exchange is a centralized repository of international AI standards with the aim to foster collaboration and responsible AI development worldwide. IEEE and its AI global standards were recognized in the 2024 United Nations AI Advisory Body’s Report, Governing AI for Humanity, which created the impetus for the AI Standards Exchange. Due to its impactful AI standards and related work, IEEE, a major standards body, was included as a partner in the establishment of the Exchange. IEEE President and CEO Kathleen Kramer, who is speaking at the AI for Good Summit this year at the High-Level AI Standards Panel,shares, “IEEE’s mission of advancing technology for the benefit of humanity is foundational to ou
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