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
Digital Reef Signs Offtake Agreement with Oreasoc Agriculture to Mitigate the Environmental Footprint of Data Centre Growth Through Rainforest Protection, Appointing Xange.com as Digital MRV Partner25.9.2026 21:19:00 CEST | Press release
The offtake agreement connects Digital Reef’s 3.3 GW data centre pipeline with environmental assets from more than 30 million hectares of Amazon rainforest across South America, where Oreasoc Agriculture works directly on the ground alongside local communities to develop sustainable economies and safeguard their territories. Xange.com’s digital MRV technology monitors both the data centres and the rainforest. At Climate Week NYC, Digital Reef and Oreasoc Agriculture Inc. sign an offtake agreement connecting Digital Reef’s 3.3 GW data centre pipeline with environmental assets exceeding 30 million hectares of South American Amazon rainforest, mitigating the environmental footprint of data centre growth through rainforest protection and restoration where Oreasoc works alongside local communities to protect biodiversity, develop sustainable economies and safeguard their territories. Xange.com are appointed as digital MRV technology partner to monitor the data centres and rainforest where D
NetApp Announces Intent to Acquire PEAK:AIO to Advance Scalable AI Infrastructure Architecture25.9.2026 15:00:00 CEST | Press release
Planned acquisition strengthens NetApp's position in the rapidly growing AI infrastructure market by bringing differentiated metadata innovation and parallel file architecture designed for AI NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced its intent to acquire PEAK:AIO, a pioneer in next-generation metadata architecture and high-performance parallel file systems. The planned acquisition is expected to accelerate NetApp's AI infrastructure roadmap by augmenting metadata services and parallel namespace innovation designed to help AI clouds scale shared storage alongside growing GPU clusters. As AI becomes embedded in every enterprise workload, organizations are confronting a new challenge: traditional storage architectures were not designed for the unprecedented scale, concurrency, and performance requirements of AI factories, AI clouds, and next-generation data-intensive applications. NetApp is building an architecture that disaggregates metadata fr
MultiBank Group Secures Two Awards at Forex Expo Dubai 202625.9.2026 14:57:00 CEST | Press release
The Group was recognised for the strength of its global institutional ecosystem and its contribution to financial markets innovation and community impact MultiBank Group, one of the world’s largest financial derivatives institutions, received two awards during its participation at Forex Expo Dubai 2026, held on 22 and 23 September at Dubai World Trade Centre. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260925539591/en/ MultiBank Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The Group was named “Best Global Institutional Financial Ecosystem of the Year” and received the award for “Excellence in Global Financial Markets Innovation and Community Impact.” The first award recognised the strength and breadth of MultiBank Group’s global institutional offering, which brings together trading, liquidity
Croma-Pharma Introduces saypha® volume prime Lidocaine25.9.2026 14:04:00 CEST | Press release
New cross-linked hyaluronic acid filler replaces saypha® volume Lidocaine, offering physicians a more versatile solution for both midface volumization and nasolabial folds Croma-Pharma introduces saypha® volume prime Lidocaine, a cross-linked hyaluronic acid dermal filler that replaces saypha® volume Lidocaine within the company's saypha® portfolio. The new product offers physicians a more versatile solution with expanded indications for both midface volumization and nasolabial folds, backed by strong clinical data. 1,2 saypha® volume prime Lidocaine demonstrated non-inferiority to comparatora in a randomized, subject- and evaluator-blinded, controlled, non-inferiority multicenter, parallel group comparison study with almost 500 patients.2 In the clinical evaluation, a high patient satisfaction highlights improved midface fullness, smoothness and contour, consistent with a rheologic profile designed to provide volumization in the mobile midface.b,2 With saypha® volume prime Lidocaine,
Abacus Global Management Completes Landmark $400 Million Securitization25.9.2026 14:00:00 CEST | Press release
~ Dual-tranche structure and investment-grade rating reflect a maturing securitization platform ~~ Transaction was oversubscribed and upsized amid strong demand from institutional fixed income investors ~~ Closing advances Abacus’s shift toward recurring, fee-related revenue ~ Abacus Global Management, Inc. (“Abacus” or the “Company”) (NYSE: ABX), a financial services company specializing in alternative asset management, with a focus on longevity-based assets and personalized financial planning, today announced the closing of a dual-tranche securitization collateralized by a diversified portfolio of life insurance policies. The total structure is valued at over $400 million including the Class A and Class B notes and the residual interest. The notes have received an investment-grade rating from a third-party rating agency. The offering was oversubscribed and was upsized in response to investor demand. Abacus expects to use the net proceeds from the transaction to support continued poli
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