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
Castles Technology Partners With Loomis Pay to Power European Expansion With Next-Generation Android Devices27.1.2026 08:00:00 CET | Press release
Cutting-edge Android payment and Point-of-Sales (POS) technology set to transform the European payments and POS landscape Castles Technology, a global leader in Android payment acceptance devices, has been selected by Loomis Pay, the POS and digital payment division of Loomis, to support its European expansion. Through this collaboration, Loomis Pay will strengthen its capacity to deliver flexible and secure POS and payment solutions tailored to merchant preferences. As well as empowering merchants and their customers to transact the way they prefer, cash, card and digital. Following an extensive market review, Loomis Pay chose Castles Technology for its leadership in Android-based payment solutions, recognized for versatility, reliability, and innovation across its latest Android devices. Loomis Pay will deploy their POS and payment services on the portable S1F4 Pro, the PINPAD S1P2 and the unattended S1U2M4, as well its CasHUB TMS and Marketplace. Castles Technology and Loomis Pay ha
EIB Provides €20 Million in Financing to SamanTree Medical for Real-Time Microscopy for Surgical Procedures27.1.2026 07:00:00 CET | Press release
EIB-funding will accelerate development of the Histolog® Scanner and reinforce commercialisation efforts across Europe and United States SamanTree Medical, a European leader in surgical imaging innovation, has secured €20 million in financing from the European Investment Bank (EIB). The operation is backed by InvestEU, the EU’s flagship program to mobilize over €372 billion in additional investment from 2021 to 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260126080876/en/ The European Investment Bank (EIB) provides €20 million in financing to SamanTree Medical, a leader in surgical imaging innovation. The financing supports the development of an advanced confocal microscopy scanner for rapid imaging of the internal microstructure of tissue samples during surgical procedures, R&D and continued development and advancement of the company's Histolog® Scanner, the first and only medical imaging device featuring massively
Ohana Development and Manchester City F.C. Sign Agreement to Launch Multi-Billion-Dirham Project in Abu Dhabi27.1.2026 07:00:00 CET | Press release
The 1.67 million square metre development is the world’s first Manchester City branded residential destination Ohana Development, a leading UAE real estate developer renowned for its luxury properties, has signed an agreement with Manchester City F.C. to launch ‘Manchester City Yas Residences by Ohana’, a first-of-its-kind branded residential community, set along Abu Dhabi’s Yas Canal waterfront. The partnership reflects a shared commitment to excellence, innovation and long-term value creation, reinforcing Abu Dhabi’s position as a global destination for world-class developments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260126122700/en/ Standing: HE Khaldoon Al Mubarak, Chairman of Manchester City Football Club. Left to right: Husein Salem, CEO of Ohana Development and Ferran Soriano, CEO of City Football Group. (Photo: AETOSWire). Spanning 1.67 million square metres, ‘Manchester City Yas Residences by Ohana’ draws on
Cirium Ascend Consultancy Named Appraiser of the Year at the Aviation 100 Awards for a Record 11th Time27.1.2026 07:00:00 CET | Press release
The fourth consecutive win recognizes Cirium’s position as the industry’s foremost provider of accurate, transparent aircraft valuations to the aviation finance and leasing sector. Cirium Ascend Consultancy has been named Appraiser of the Year 2026 in the Airline Economics Aviation 100 Global Leaders Awards, the team’s 11th title in 15 years. The Consultancy is a highly respected division of Cirium, the world’s most trusted source of aviation analytics. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260126679094/en/ AOTY Win The Appraiser of the Year award recognizes the aircraft appraisal provider that has demonstrated the greatest contribution to the industry over the past year. The fourth consecutive win reflects the trust placed in the Ascend Consultancy team and their work by their industry peers. The Aviation 100 Global Leaders Awards celebrate the best companies, individuals and transactions in the aviation finance an
Access Advance Extends HEVC Advance Rate Increase Deadline27.1.2026 02:00:00 CET | Press release
Provides New Licensees the Opportunity to Join at Current Royalty Rates Access Advance LLC today announced that the Licensors of HEVC Advance have approved an extension of the deadline for new Licensees to secure current royalty rates and caps through 2030. Companies that become Licensees of the HEVC Advance program on or before June 30, 2026 will secure current royalty rates for both ongoing royalties and calculation of royalties for past sales. This is a temporary postponement of the 25% increase in rates and caps applicable to Licensees who sign up after the previous December 31, 2025 deadline. The extension also applies to the Multi-Codec Bridging Agreement ("MCBA"), which provides a single discounted royalty rate structure for Licensees in both the HEVC Advance Patent Pool and the VVC Advance Patent Pool. Licensees who execute the MCBA by June 30, 2026 will benefit from royalty caps that match the royalty caps for the VVC Advance program. The extension follows Access Advance's rec
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