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
Thales to Strengthen Romania’s Airspace Protection With Twelve Ground Master 200 MM/A Radars24.7.2026 10:05:00 CEST | Press release
The Romanian General Directorate for Armaments and the French Direction Générale de l’Armement (DGA – the French defence procurement agency) have signed an agreement to supply twelve Thales GM200 Multi-Mission All-in-one (GM200 MM/A) radars to protect the Romanian airspace. This government-to-government agreement underlines the high level of partnership between France and Romania, within the framework of the European Union’s SAFE funding programme, in order to bolster Europe’s defence capabilities. The GM200 MM/A is part of Thales’ proven Ground Master radar family, which has already been deployed in over 40 countries, including now in Romania. In a context of growing collaboration between European nations to bolster collective security, the Romanian General Directorate for Armaments has just signed a landmark agreement with France’s Direction Générale de l’Armement (DGA) to acquire twelve Thales Ground Master 200 Multi-Mission All-in-one (GM200 MM/A) radars. This government-to-governm
Comsysto Reply Supports Audi in Evolving Its B2B Used Car Platform With an AI-Based Multi-Agent System24.7.2026 10:00:00 CEST | Press release
Comsysto Reply, the Reply Group company specialised in agile software development and cloud-native solutions, has partnered with Audi on the ongoing development of its “Used Car Platform”, the company’s central digital marketplace for B2B used car trading. A tailored multi-agent solution accelerates software development, reduces repetitive activities, and enables faster delivery of new features. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260724143396/en/ Comsysto Reply, the Reply Group company specialised in agile software development and cloud-native solutions, has partnered with Audi in evolving its digital marketplace for B2B used car trading with an AI-based multi-agent system The platform represents a key digital sales channel for Audi’s used car sector. Since 2025, it has accounted for nearly 100% of the car manufacturer's B2B business. Building on this operational relevance, Audi and Comsysto Reply have introduced
Samsung Epis Holdings Reports Second Quarter and Half-Year 2026 Financial Results24.7.2026 09:20:00 CEST | Press release
Samsung Bioepis reports revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026, recording 6% year-over-year growthExpanding direct commercialization in Europe to five products with the launch of OPUVIZ™ 40 mg/mL vial, a biosimilar to Eylea1 (aflibercept)First to announce preliminary results from Phase 1, 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda2 (pembrolizumab)Samsung Epis Holdings continuing to secure next-generation growth engines through establishment of a global R&D hub in China Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the second quarter and first half of fiscal year 2026. “We delivered solid first-half 2026 results, achieving 6% growth year-over-year. This performance demonstrates the resilience of our biosimilar portfolio in the global market," said Kyung-Ah Kim, President and Chi
Ant International’s Alipay+ Adds New Bank Partners Amid Cross-border Mobile Payment Boom in Asia Pacific24.7.2026 06:10:00 CEST | Press release
Through Alipay+, banks are able to quickly build new revenue streams, increase digital engagement and introduce new value-added services for users through cross-border payments Alipay+, Ant International's unified wallet gateway, is adding more bank partners to its network of over 50 leading digital wallets and financial institutions. Its global bank partners range from incumbent banks to fully digital banks. The latest banking partner to join Alipay+ is Hang Seng Bank, Alipay+’s first banking partner in Hong Kong. Hang Seng Mobile App users can now make payments via QR code scan in the Chinese Mainland and overseas by simply using the Hang Seng Mobile App at over 100 million merchants across more than 55 countries/regions. Accelerating revenue growth through cross-border mobile payments Demand for outbound cross-border payments from Asia Pacific is projected to increase faster than the global average. Alongside growing adoption of digital wallets, consumer-to-consumer (C2C) and consum
mimik Operationalizes Agentic AI on the AMD Ryzen™ AI Embedded X100 Series23.7.2026 20:30:00 CEST | Press release
mimik today announced mimOE™ Embedded Edition, a package of its Agentix Operating Engine and a set of purpose-built tools for the AMD Ryzen™ AI Embedded X100 Series processor, the newest processor in a family designed for physical AI, autonomous systems, and industrial automation. Available to download today, mimOE Embedded Edition gives OEMs, tier-1 suppliers, system integrators, and agent developers the path to operationalize Agentix-Native systems (aka Agentic AI), in which autonomous agents can reason, coordinate, and act directly on devices, from PoC to scaled operations with certainty. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260723555565/en/ Agentic AI operations are both CPU and GPU bound. Enterprises can now scale with certainty. Generative AI has centered on the GPU. Agentix-Native systems must spread the work. In a real multi-agent workflow traced by mimik, more than 80 percent of operations were CPU work: d
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