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
Festo, Softcat, ANS Group and SCC Demonstrate the Business Impact of AI-Powered Observability5.11.2026 10:00:00 EET | Press release
LogicMonitor®, the AI-first platform for Autonomous IT, announced the 2026 Elevate Award winners today at its Elevate Community Conference in London. The annual awards recognize LogicMonitor customers and partners that are achieving measurable business and operational outcomes through AI-powered observability. From consolidating 90% of monitoring tools and reducing alert noise by 85% to cutting observability case volumes by 45%, this year's EMEA winners demonstrate how organizations are simplifying complex IT environments, improving resilience and putting AI-powered operations into practice. “This year's EMEA Elevate Award winners are proving that the path to Autonomous IT starts with real, measurable improvements in how organizations operate,” said John Grosshans, President of Field Operations, LogicMonitor. “They're reducing complexity, giving teams time back and using AI to make better decisions and take more effective action. We're proud to recognize their achievements and the impa
New AGCO Power CORE Engines to Power Two New Tractors at EIMA 20265.11.2026 08:00:00 EET | Press release
At EIMA International in Bologna, Italy, on November 10–14, 2026, visitors will be able to see how the AGCO Power CORE75 engine platform supports the different requirements of the Massey Ferguson new model MF 7S MARK 2 range and Valtra’s new sixth-generation Valtra T Series. A CORE75 engine will also be on display at the Valtra stand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104588496/en/ Massey Ferguson 7S MARK 2 The CORE engine family represents AGCO Power’s investment in a completely new engine platform at a time when few manufacturers are making comparable commitments to off-highway combustion engine development. The CORE engine family is designed to meet different power requirements, emissions regulations and machine integration needs. Its design combines fuel efficiency, strong low-speed torque and responsive performance for applications that demand dependable power over long working days. The family includes
SPIE Announces 2027 Prism Awards Finalists for Best Photonics Products4.11.2026 22:22:00 EET | Press release
SPIE, the international society for optics and photonics, has announced finalists in the seven categories for the 2027 Prism Awards, which recognize remarkable new photonics products on the market. Winners will be announced during the awards ceremony at SPIE Photonics West on 3 February 2027 in San Francisco, California. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104613876/en/ SPIE has announced the finalists for the 2027 SPIE Prism Awards, which recognize optics and photonics innovations. Recipients will be announced at the awards ceremony on 3 February 2027 at SPIE Photonics West. During the Prism Awards, SPIE will also announce the winner of the SPIE Catalyst Award, honoring a for-profit company with social or environmental programs that have made significant advances in workplace opportunity, community engagement, or environmental progress. Finalists for this year’s Catalyst Award, now in its fourth year, are Lume
Every Critical System Should Have a Backup: Elliptic Opens Up Fast Track Monitoring to the Crypto Industry4.11.2026 22:07:00 EET | Press release
Elliptic, the leader in on-chain risk management, is making Fast Track Monitoring available to firms with digital assets exposure as a back up screening option for firms that need business continuity, if their primary screening service is unavailable and they need a second option. Criminals are increasingly using AI to scale their attacks, so on-chain risk now moves at machine speed. Compliance teams need the broadest range of options to keep screening every wallet and transaction, and a second screening provider builds resilience into any on-chain risk management approach. Elliptic recommends every business has one in place. Organizations that rely on a single screening vendor can also still need a second option. Fast Track Monitoring gives compliance teams real-time wallet and transaction screening powered by Elliptic Lens, with a clear, explainable risk score on every wallet and transaction. When screening stops, a compliance lead faces two hard choices: hold customer withdrawals, o
Smartsheet Adds New AI Agents, Integrations and Security Advancements at ENGAGE 20264.11.2026 20:00:00 EET | Press release
Smartsheet, the AI-powered enterprise work management platform, today announced new platform capabilities at ENGAGE 2026, its annual customer conference. The company introduced new AI agents, agentic workflows, system integrations and security controls built to end execution drift: the costly gap between what an organization sets out to deliver and what it actually delivers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104562370/en/ Today, Smartsheet introduced new AI agents, agentic workflows, system integrations and security controls built to end execution drift. AI has helped teams move faster, but it is also widening execution drift. As AI agents join people, partners and systems in doing the work, three problems keep that distance from closing. Data is scattered across disconnected tools, so no one sees the full picture. AI is arriving faster than IT can govern it, so leaders hesitate to scale it. Most AI also lack
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