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
Neural Concept Closes $100M Funding Round Led by Growth Equity at Goldman Sachs Alternatives to Scale AI-Native Engineering18.12.2025 17:00:00 CET | Press release
New capital accelerates Neural Concept’s ability to deliver transformative technologies and enterprise-wide AI impact across advanced industrial workflows.Platform delivers CAD-native, physics-aware AI and deep reasoning for engineering, saving customers $50 million annually, reducing late-stage redesigns by 30-50% and accelerating time to market by up to two years.The company has generated a fourfold increase in enterprise revenue over the past 18 months.More than 50 global companies are actively relying on the platform, including General Motors, General Electric Vernova, Leonardo Aerospace, Eaton, Safran, Renault Group and multiple Formula 1 teams. Neural Concept, a global AI platform and leader in Engineering Intelligence powering next-generation product development, today announced it raised a $100 million Series C funding round led by Growth Equity at Goldman Sachs Alternatives, with existing investors Forestay Capital, Alven, HTGF, D.E. Shaw Ventures and Aster Capital. This press
Croma-Pharma Introduces New Medical Device for the Preparation of Autologous PRP | Fluid- PRF18.12.2025 16:57:00 CET | Press release
Croma-Pharma, a global player in minimally invasive aesthetic medicine, proudly announces the launch of its new medical device that is used for the preparation of autologous Platelet-Rich Plasma (PRP) | Fluid-Platelet-Rich Fibrin (Fluid-PRF).1 This launch represents continued progress in Croma’s mission to provide healthcare professionals state-of-the-art tools for their practice. With its innovative design and optimized separation technology, Exprecell™ enables the efficient preparation of autologous blood concentrates, without the use of anticoagulants, resulting in the formation of Fluid-PRF, a biologically active concentrate that retains the regenerative properties of platelets and leukocytes, yet stays liquid for a defined period.1 What makes Exprecell™ special?MDR certification: Exprecell™ is MDR-certified, meeting stringent EU regulatory requirements to ensure the safe, controlled and standardized preparation of autologous Platelet-Rich Plasma (PRP) | Fluid-Platelet-Rich Fibrin
Laserfiche is a Leader in Info-Tech Research Group’s Enterprise Content Management - Enterprise Data Quadrant18.12.2025 16:00:00 CET | Press release
AI-driven document management and process automation position Laserfiche highest for Product Features and Satisfaction. Laserfiche — the leading SaaS provider of intelligent content management and business process automation — is a Leader in the Enterprise Content Management – Enterprise Data Quadrant Report from Info-Tech Research Group. With the most reviews of any vendor and a composite score of 9.1, Laserfiche was positioned highest for Product Features and Satisfaction. “Laserfiche is honored to be recognized as a Leader in the ECM Data Quadrant at a moment when AI is transforming every aspect of how organizations create value from their data,” said Thomas Phelps IV, CIO and SVP of corporate strategy at Laserfiche. “We’re especially appreciative of the more than 400 reviews contributing to our +94 net emotional footprint and the 99% of users who indicate ‘they love the Laserfiche platform.’” The Info-Tech Data Quadrant evaluates and ranks products, capabilities and features based
Interactive Brokers Redesigns IBKR GlobalTrader App for Simpler, Smarter Mobile Trading18.12.2025 16:00:00 CET | Press release
New mobile experience offers faster navigation, AI-driven market insights, and integrated access to forecast contracts for investors worldwide Interactive Brokers (Nasdaq: IBKR), an automated global electronic broker, today announced the launch of its redesigned IBKR GlobalTrader mobile app. The updated trading platform reflects the firm’s commitment to delivering intuitive, accessible tools for investors at every experience level. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218345494/en/ IBKR GlobalTrader The new version offers a faster and more powerful interface with new capabilities, including integrated access to forecast contracts, AI-generated news summaries, and a redesigned Explore section that helps investors identify opportunities across global markets. Investors can trade stocks, ETFs, options, access cryptocurrencies, and more – all from a streamlined mobile app. IBKR GlobalTrader complements IBKR Mobile,
The Rock-It Company Appoints David Byrnes as Chief Financial Officer18.12.2025 15:00:00 CET | Press release
Entertainment and media veteran joins as The Rock-It Company embarks on a new chapter of global growth and acceleration The Rock-It Company, the global leader in specialty logistics across live events and luxury goods, announced today the appointment of David Byrnes as Chief Financial Officer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218600008/en/ David Byrnes, Chief Financial Officer, The Rock-It Company With decades of experience steering groundbreaking multimedia and live experience projects globally, David joins The Rock-It Company from Sphere Entertainment, where he most recently served as Executive Vice President and Chief Financial Officer. His career includes multiple senior leadership roles, including CFO of Madison Square Garden Entertainment Corp., Executive Vice President of Corporate Finance at Paramount, and a variety of senior leadership positions at CBS Corporation. He also spent five years at ADP, i
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