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
JPMorganChase Announces Intention to Build a New Three-Million Sq Ft Landmark Tower in London27.11.2025 07:00:00 CET | Press release
Including the cost of construction, the project could contribute £9.9 billion ($13 billion) over six years to the local economy, including an additional 7,800 jobs across construction and other local industriesThe new building would house up to 12,000 people and serve as the firm’s principal headquarters in the UK and its most significant presence in Europe, the Middle East and Africa (EMEA). JPMorganChase is a major employer in the UK with 23,000 employees there in totalJPMorganChase already contributes nearly £7.5 billion ($9.8 billion) annually to the local economy, supporting 38,000 jobs across surrounding industriesThe building would be one of the largest and most sophisticated in Europe with more than three-million square feet (Gross Internal Area) of space, reinforcing London’s status as a leading financial centre on the global stagePlans are subject to a continuing positive business environment in the UK and the firm receiving the necessary approvals and agreementsIn addition t
WattCycle Unveils 2025 Black Friday Battery Sales with Europe-Wide Savings on LiFePO4 Batteries27.11.2025 07:00:00 CET | Press release
WattCycle today announces the launch of its Europe-wide Black Friday battery deals 2025, offer up to 60% off for LiFePO4 batteries plus an additional 8% discount at checkout with no minimum order value. All EU users are covered by 30 days price protection policy to ensure they secure the best available price during the promotion. Get your Battery Coupon Code: BlackFriday8% Of particular note is the WattCycle 12V 314Ah battery, featured as the most heavily discounted product in the 2025 Black Friday sales. The battery is offered at €489,99 (was €1.299,99), representing a 60% discount. After using the "BlackFriday8%" battery coupon code only €450.79. This battery delivers 4.019Wh of usable energy and engineered with advanced 200A BMS and EV A+ Grade cells rated for 15.000+ cycles, offering a reliable long-term power solution for diverse applications. WattCycle Marine Solution The European boating season underscores the need for dependable, lightweight power. WattCycle 12V 100Ah TM Blueto
Vietnam’s C4IR and Ant International Partner to Accelerate Innovation as Ho Chi Minh City Eyes Becoming International Financial Centre27.11.2025 04:46:00 CET | Press release
Ant International will be recognised as an Official Partner of the HCM City government, strengthening public-private collaboration to drive long-term sustainable growthHCM City, C4IR and Ant International will work together comprehensively across empowering SMEs, globalising the local digital economy, implementing emerging technologies, cultivating joint innovation and developing talent The Vietnam Centre for the Fourth Industrial Revolution (C4IR Vietnam), established by the World Economic Forum and the People’s Committee of Ho Chi Minh City, and Ant International today announced a strategic partnership through a Memorandum of Understanding (MoU) to advance Vietnam’s digital economy, foster innovation, and support Ho Chi Minh City’s (HCMC) ambition to become an international financial centre and regional fintech hub. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126280083/en/ The partnership was announced at the Ho Chi
LambdaTest and SVAM International Inc. Announce Partnership to Transform Quality Engineering for Businesses26.11.2025 18:00:00 CET | Press release
The alliance empowers enterprises with accelerated SDLC cycles, reduced testing effort, and modern AI-driven digital transformation capabilities LambdaTest, a Gen-AI native quality engineering platform, announced a partnership with SVAM International, Inc., a global leader in digital transformation services. This strategic alliance marks a significant step forward in their mission to transform quality engineering for businesses worldwide. The partnership allows LambdaTest to extend its AI-native quality engineering capabilities into SVAM’s extensive digital transformation ecosystem. By integrating with SVAM’s experience in large-scale application development, testing, and delivery across major New York State and City agencies, as well as their platform expertise across Salesforce, ServiceNow, and Dynamics365, LambdaTest will empower more enterprises to modernize their software delivery pipelines. With LambdaTest’s intelligent test orchestration and execution engine at the core, teams c
GLORY Acquires Remaining Equity Shares in Acrelec Group26.11.2025 16:11:00 CET | Press release
Acrelec becomes a wholly owned subsidiary of Glory Glory Global Solutions (International) Ltd, a wholly-owned subsidiary of GLORY Ltd. [TYO:6457], has announced the acquisition of the remaining equity shares in Acrelec Group SAS. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126039437/en/ Acrelec is a global technology company focused on reinventing the customer experience for restaurant and retail brands. Leveraging decades of software, hardware and service expertise, the company develops and integrates new platforms that increase customer engagement, optimize efficiency and improve operations. With over 120,000 installations across more than 70 countries, Acrelec counts many of the world’s best-known restaurant mega-brands among its customers. We announce that Jalel Souissi has left the Acrelec Group following the completion of the recent share acquisition. Jalel Souissi has played a pivotal role in the development and
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