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
Swiss Leader Leonteq Chooses ActiveViam to Deliver High‑Performance FRTB Risk Analytics10.2.2026 09:00:00 CET | Press release
ActiveViam, a global leader in real‑time, multidimensional risk analytics for capital markets, today announced that Leonteq, one of the leading Swiss providers of structured products, has implemented Atoti to calculate Market Risk Capital Charges under the Standardized Approach of the Fundamental Review of the Trading Book (SA-FRTB). ActiveViam’s flagship product, Atoti, is being used by Leonteq as its FRTB reporting solution to the Swiss Financial Market Supervisory Authority (FINMA). Switzerland implemented FRTB for its banks on 1st January 2025 and FINMA recently extended its scope to include Leonteq. When the FRTB implementation deadlines became clear, Leonteq evaluated several vendors for a solution that could integrate with its existing pricing engines. After a detailed assessment, it selected Atoti. The solution provides dashboards and preconfigured reports that meet FINMA’s requirements, along with analytics aligned to the ISDA Unit Tests and additional capabilities such as wha
Bending Spoons offers €1.5 million in tech scholarships through new Fellowship program10.2.2026 09:00:00 CET | Press release
Today Bending Spoons announced the launch of the Bending Spoons Fellowship, committing up to €1.5 million to support Europe’s most outstanding computer science students through the program. The fellowship will award ten scholarships—each worth €50,000 per year and renewable for up to three years—to high-achieving university students in computer science and related fields across Europe and the UK. “We think exceptional talent deserves exceptional opportunities,” said Costanza Mazzei, the Bending Spoons talent manager leading the program. “With the Bending Spoons Fellowship, we aim to give Europe’s most driven students the freedom, resources, and guidance to reach the highest levels of excellence.” In addition to financial support, Fellowship participants will benefit from individual mentorship and may choose to participate in an optional paid summer internship at Bending Spoons. The fellowship is the latest initiative from Bending Spoons to support emerging technical talent. It builds o
Ralph Haupter Joins Warburg Pincus as an External Senior Advisor10.2.2026 09:00:00 CET | Press release
Seasoned Technology Executive to Support European Technology Group Warburg Pincus, the pioneer of private equity global growth investing, today announced that Ralph Haupter will serve as an External Senior Advisor to its European Technology team. Mr. Haupter, Executive Vice President and Chief Revenue Officer for Small Medium Enterprises and Channel (SME&C) at Microsoft, will take on this personal engagement to help the firm identify and evaluate new investment opportunities across the software and technology sectors. He will also play an active role in value creation across the firm’s existing portfolio. Mr. Haupter brings over 25 years of global operating experience and deep expertise in technology innovation and transformation. At Microsoft, he leads a global organization that works with the company’s extensive partner ecosystem to empower small and medium businesses worldwide. Previously, he held senior leadership roles across Europe, Asia, and the Americas, including President of
CapVest Enters Exclusive Discussions With HLD on the Proposed Acquisition of TSG10.2.2026 09:00:00 CET | Press release
HLD and management to retain significant minority stakes in TSG, partnering with CapVest on a shared vision to lead the company into its next phase of global growth CapVest Partners LLP (“CapVest”), a leading New York and London based investment firm, and HLD, the entrepreneurial European investment group, have entered exclusive discussions on CapVest’s proposed acquisition of a majority stake in TSG, a European leader in technical services for critical energy infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260210375858/en/ Headquartered in Paris, France, TSG is a European leader in technical services for the energy industry with a pan-European footprint in over 30 countries and employing over 7,000 people. Originally focused on fuel station and private fleet energy infrastructure and systems, since HLD’s acquisition of the company in 2020 TSG has undergone significant transformation as a primary enabler of th
MASARAT Mobility Park Welcomes FPI Gulf as Anchor Tenant for Advanced Automotive Parts Manufacturing10.2.2026 08:48:00 CET | Press release
MASARAT Mobility Park has entered into a development lease agreement with FPI Gulf to establish an automotive parts manufacturing facility, marking a key milestone in the Park’s development. This agreement strengthens MASARAT Mobility Park’s position as the premier destination for localizing the automotive and mobility value chain in Saudi Arabia. At the PIF Private Sector Forum 2026, MASARAT Mobility Park announced the signing of a development lease agreement with Fortune Parts Industry Gulf (FPI Gulf), a Joint venture between Thailand based FPI Group and local partner Fuel Autoparts Company. This milestone represents a significant step in the Park’s development and supports the localization of automotive manufacturing in the Kingdom, in line with Vision 2030. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211304060/en/ From left to right: Noppawit Tanadumrongsak, Managing Director of FPI India; Abdulrahman Binmahfooz, M
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