AMRA Medical Secures European Medical Device Regulation Certificate for AMRA® Profiler 4, Highlighting Yet Another Regulatory Win
29.8.2024 16:55:00 EEST | 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240829196647/en/
Contacts
Marie Börjesson
VP Brand & Marketing
marie.borjesson@amramedical.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
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
Angelalign Technology (6699.HK) Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 21:56:00 EET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 19:46:00 EET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
Credit Derivatives Determinations Committees Membership applications for 202627.3.2026 18:30:00 EET | Press release
DC Administration Services, Inc. (DCAS) would like to invite all interested Members of ISDA to apply for a position as a member of the Credit Derivatives Determinations Committees. There is a separate Determinations Committee for each of the relevant regions. Members of ISDA may apply for membership as either a Dealer Member of the Determinations Committees or a Non-Dealer Member of the Determinations Committees (as applicable). Parties wishing to apply for such a position should carefully review and submit either an executed Dealer Participation Letter (for a prospective Dealer Member) or an executed Non-dealer Committee Participation Letter (for a prospective Non-Dealer Member) by 5pm (New York time) on Friday, April 3, 2026. CCPs may also apply to participate as a CCP Member by submitting a Participating CCP Institution Letter. For more information on the process and to download the form of the relevant letter, please visit https://www.cdsdeterminationscommittees.org/about-dc-commit
Klarna Partners With EuroParcs to Offer Flexible Payments for Holiday Park Stays Across Europe27.3.2026 16:04:00 EET | Press release
Klarna, the global digital bank and flexible payments provider, today announces a new partnership with EuroParcs, one of Europe's fastest-growing holiday park operators. The collaboration gives holidaymakers in Germany, the Netherlands, Belgium, and Austria more flexibility in how they pay for their getaway. Guests booking through EuroParcs can now choose from a range of Klarna payment options tailored to their market: Germany & Austria: Pay in Full, Pay in 30 Days, Pay in 3, and Financing Netherlands: Pay in Full, Pay in 30 Days, and Pay in 3 Belgium: Pay in Full and Pay in 30 Days Nicole Defren, Head of Europe at Klarna, says: "Booking a holiday should feel exciting, not complicated – and that includes how you pay for it. With Klarna, EuroParcs guests can choose the payment option that suits them best, whether that's paying upfront, in a few weeks, or spreading the cost over time. From a cosy chalet on the Veluwe to a luxury villa in the Austrian Alps, we're making it easier for fami
Askey and Canoga Perkins Announce Strategic Collaboration at MWC Barcelona to Deliver Rapid-Deploy 5G Critical Communications Solutions27.3.2026 13:00:00 EET | Press release
Askeyand Canoga Perkinsannounced at Mobile World Congress Barcelona a Global Partnership to Deliver SyncMetra® Network Connectivity Solution, combining Canoga Perkins’ software-defined, IT-operated private 5G network transport along with Askey’s carrier-grade 5G radio access technology. At MWC Barcelona 2026, Askey Computer Corporation and Canoga Perkins announced a strategic partnership to deploy Canoga Perkins' SyncMetra® Platform across enterprise and service provider markets with Askey. This partnership pairs Askey’s carrier-grade radio access capabilities with Canoga Perkins’ industry-leading time-sensitive networking (TSN) and synchronization technology, enabling customers to simplify deployment of ultra-low-latency, highly reliable network services for 5G, edge compute, industrial automation, and mission-critical enterprise applications. The partnership enables joint go-to-market efforts, integrated product offerings, and expanded access to SyncMetra through Askey’s sales channe
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