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
Airship Announces Results Guarantee; Releases Commissioned Study Finding 476% ROI for Composite Organization22.7.2026 17:00:00 CEST | Press release
Airship stands behind results with new guarantee offer*; also launches a commissioned study quantifying how a composite organization moved past vanity metrics to drive $7.3M in value Airship, the mobile-first customer experience platform leader, today announced its Airship Results Guarantee, a corporate commitment to achieve predetermined business outcomes for new customers. Concurrently, the company released the results of a separate, commissioned Total Economic Impact™ (TEI) study conducted by Forrester Consulting on behalf of Airship, July 2026. The study found that a composite organization based on interviewed customers achieved a 476% Return on Investment (ROI) with a payback period of less than six months. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722832535/en/ Airship has launched a new results guarantee offer to stand behind its value. Alongside this offer, the team shared the results of a new Total Economic
Arrakis Comes out of Stealth With $38M to Help Industrial Enterprises Compete in the AI Era22.7.2026 15:56:00 CEST | Press release
Funding led by Blossom Capital with participation from Accel, GFC, MainObject, and Rerail, bringing total raised to around $38 million in just six months. Arrakis helps industrial companies deploy AI agents into mission-critical operations, tackling the "last mile" challenge that prevents most AI projects reaching production. The funding will enable office openings in New York and the Middle East, platform development and AI deployment in the world's most operationally complex industries. Arrakis, the AI deployment company helping industrial companies install AI agents for mission-critical operations, today announced a $30 million Series A led by Blossom Capital, with participation from existing investor Accel, which also led the company's $7.5 million seed round. The round brings total funding to around $38 million and includes backing from prominent technology leaders, including Olivier Pomel, founder and chief executive of Datadog, Olivier Godement, OpenAI’s Head of business product
Vultr and AMD Support the University of Cambridge's TESSERA AI Project to Accelerate Global Environmental Monitoring22.7.2026 15:00:00 CEST | Press release
Cambridge University's Energy & Environment Group Deploys Planetary-Scale Foundation Model on Vultr Cloud GPU Infrastructure Powered by AMD Instinct™ MI325X GPUs Vultr, the world’s largest privately-held cloud infrastructure company, and AMD, a leader in high-performance and AI computing, have announced their support for the University of Cambridge's Energy & Environment Group in developing TESSERA, a groundbreaking AI foundation model designed to monitor environmental change internationally at unprecedented scale. Vultr is providing the computational infrastructure, based on AMD Instinct MI325X accelerators, necessary to generate global embeddings covering Earth's land surface from 2017 to 2025, enabling applications in agriculture, biodiversity conservation, and renewable energy infrastructure monitoring. The collaboration represents a significant advancement in applying artificial intelligence to planetary conservation challenges. TESSERA processes data from European Space Agency Se
StructureCraft Scales Data-Driven Design on NetApp22.7.2026 14:00:00 CEST | Press release
Structural engineering firm modernizes data infrastructure to support global collaboration NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced that StructureCraft, an award-winning global structural engineering and construction firm known for complex timber and hybrid builds, is now using NetApp to modernize and create an AI-ready data infrastructure. The new infrastructure enables the company’s employees to collaborate globally, store and manage large-scale design workloads, and take advantage of AI-driven tools on a scalable, centralized platform. StructureCraft specializes in innovative timber engineering, structural design, and sustainable building solutions for large-scale architectural projects worldwide. Its globally distributed team delivers complex projects across North America, Europe, and Asia, guided by a core purpose to engineer and build beautiful, efficient structures. The StructureCraft team regularly takes on complex projects such as de
OneSpan Introduces DigipassONE, Bringing a Unified Platform Approach to Authentication Modernization22.7.2026 14:00:00 CEST | Press release
A new authentication platform helps financial institutions support diverse customer authentication preferences while modernizing at their own pace Organizations are under increasing pressure to modernize authentication while supporting existing infrastructure, meeting evolving regulatory requirements, deploying emerging technologies, and reducing operational complexity. For financial institutions in particular, authentication modernization must balance security, compliance, and operational efficiency while meeting the evolving expectations and preferences of their customers. Yet the journey to modern authentication is rarely a single technology transition. Organizations must continue supporting multiple authentication methods while gradually adopting new technologies, making it essential to modernize without disrupting existing environments, user experiences, or business operations. To help organizations navigate this transition, OneSpan Inc. (NASDAQ: OSPN) today announced DigipassONE™
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