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
Andersen Consulting styrker sine kompetencer inden for organisatorisk transformation med Afiniti8.5.2026 20:45:00 CEST | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med Afiniti, et globalt konsulentfirma inden for forretningstransformation med hovedkontor i Storbritannien, der hjælper organisationer med at levere og opretholde komplekse forandringsprojekter. Afiniti blev stiftet i 2003 og er et globalt konsulenthus inden for forretningsforandring med base i Storbritannien og USA. De støtter klienter gennem komplekse transformationer på tværs af mennesker, processer, systemer og data, og de skaber mærkbare forandringer gennem kreative konsulentydelser. Virksomheden betjener primært stærkt regulerede, sikkerhedsdrevne og aktivtunge organisationer med store, geografisk spredte arbejdsstyrker inden for sektorer som energi, forsyning, biovidenskab, transport og byggeri. Afiniti samarbejder med velkendte brands om at levere ekspertise fra start til slut på tværs af organisatoriske, digitale og ai-baserede transformationer samt ændringer i kultur og driftsmodeller. Dette gælder især komplekse scenarier s
Verdantis Launches MRO360 “The World's First AI-Native Spare Parts Intelligence Platform”8.5.2026 15:40:00 CEST | Press release
MRO360 is the first milestone in Verdantis's journey to deliver the industry's first fully AI-native Enterprise Asset Management solution. Verdantis today announced the global launch of MRO360, a purpose-built AI platform that transforms how asset-intensive organizations manage their MRO spare parts inventory. Designed for manufacturers, oil and gas operators, mining companies, utilities, and other industrial enterprises, MRO360 deploys nine interconnected AI agents that continuously forecast demand, score parts criticality, manage obsolescence risk, calculate dynamic reorder points, helps intercompany plant transfer thereby realizing the exact dollar value of every optimization opportunity across a spare parts catalog in real time. Unlike traditional EAM and CMMS platforms built on static rules, MRO360's agents adapt continuously as demand patterns, supplier performance, and equipment health evolve. For the first time, a maintenance planner can see which work orders are at supply risk
Cyble Positioned as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies8.5.2026 15:22:00 CEST | Press release
Cyble today announced it has been recognized as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies. The company believes this recognition underscores Cyble’s mission to make threat intelligence truly operational—delivering AI-native capabilities that enable enterprises, government agencies, and MSSPs to shift from reactive security to proactive, intelligence-driven defense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508164528/en/ Cyble Named a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies "Security teams are under constant pressure to respond faster with greater accuracy," said Beenu Arora, Co-Founder and CEO, Cyble. "We believe this recognition highlights our focus on delivering intelligence that drives real outcomes—cutting through noise, accelerating response, and enabling confident decision-making at scale." Intelligence That Acts
WHOOP Expands Health Platform with On-Demand Clinician Access and New AI Features8.5.2026 15:00:00 CEST | Press release
New updates introduce a more personalized, data-driven member experience—bridging the gap between continuous biometrics, real-world context, and clinical insight WHOOP, the human performance company, today announced a new suite of health and AI-driven enhancements and feature updates across the WHOOP memberships, marking a major step forward in its evolution into an intelligent health platform. These updates deepen the company’s commitment to delivering highly personalized, accurate, and actionable insights. They signal the company’s expansion beyond performance optimization into clinical-grade health support. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508464188/en/ WHOOP Expands Health Platform with On-Demand Clinician Access and New AI Features “WHOOP is a membership, and we take that seriously,” said Ed Baker, Chief Product Officer of WHOOP. “We’re always asking how we can deliver more value to our members, and the
Reply Presents the Jury of the Second Edition of the AI Music Contest: This Year Again, Finalists Will Perform on the NOVA Stage of Kappa FuturFestival in Turin8.5.2026 13:24:00 CEST | Press release
Agoria, Max Cooper, Fleur Shore, Tini Gessler, Ali Demirel, Albi Scotti, Oliver Bohl and Sarah Grimaldi join the jury of the second edition of the competition dedicated to the dialogue between artificial intelligence and live performance. Reply, [EXM, STAR: REY], an international group specialised in the development of new AI-enabled business models and always distinguished by a strong drive for innovation, renews its commitment to creative experimentation with the second edition of the ReplyAI Music Contest. The initiative, organised in collaboration with Kappa FuturFestival—one of Europe’s leading festivals dedicated to electronic music—takes the form of an international competition aimed at creatives and innovators who use AI technologies to explore new ways of integrating sound and image, enhancing the role of artificial intelligence in live performances. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508361016/en/ Th
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