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
Phenom Adds Major Headline Speakers as IAMPHENOM Europe Approaches Sold-Out Status6.10.2026 15:30:00 CEST | Press release
Second wave of esteemed speakers to bring real-world guidance on applying AI, agents and automation to improve hiring, development and retention Phenom, the leader in applied AI built to redesign work operations for hiring faster, developing better and retaining longer, today announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006714151/en/ Phenom announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. The two-day conference gives attendees what other HR events can’t: an inside look at AI agents already in production, automated workflows tailored to specific business contexts and the dramatic results they are already delivering. Across keynotes, customer
European Firms Struggle to Keep Pace with Growing DSAR Demands, New Reveal Study Finds6.10.2026 15:00:00 CEST | Press release
With 86% of organisations still lacking dedicated DSAR technology, fewer than half of requests are completed within the one-month window GDPR requires, even as spending climbs New research published today byReveal, the provider of integrated AI-native platforms spanning the dispute resolution lifecycle, found that large European organisations complete fewer than half of data subject access requests (DSARs) within the one-month deadline required under the General Data Protection Regulation (GDPR), a shortfall the study ties directly to a near-universal absence of purpose-built technology. Nearly nine in 10 organisations still run DSARs on manual or general-purpose workflows, with no dedicated tooling in place. The report, based on a survey of 213 legal and privacy professionals at large European enterprises, is the first of its kind to benchmark how organisations across the region are managing DSAR compliance at scale. The findings expose structural inconsistencies between how organisat
New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support6.10.2026 15:00:00 CEST | Press release
Rimini Street and DBTA/Unisphere Research survey finds 66% are already using or are considering third-party support Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced findings from the 2026 IT Virtualization Survey – What’s Next for VMware Users, a new global survey of nearly 300 VMware user organizations conducted by Unisphere Research on behalf of Rimini Street. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006014490/en/ New Global Survey Finds Majority of VMware Users Are Choosing Alternative Paths for Cost Control, Roadmap Flexibility and Better Support Cost Cited as the Number One Factor in Seeking Alternative VMware Solutions Key Findings: 90% of respondents said they are considering alternatives to VMware due to higher licensing costs, while 54% cited the end of perpetual license supp
Xsolla Shows Brand Owners How to Create Value for Video Players at Brand Licensing Europe With Rewarded Marketing6.10.2026 15:00:00 CEST | Press release
Twenty-One Years of Game Commerce Comes to ExCeL London, October 6 to 8, With a New Way for Brands to Reward the Players They Have Been Trying to Reach for Years Xsolla, a global commerce company, today announced it will be at Brand Licensing Europe 2026 at ExCeL London, October 6 to 8, to show brand owners how to engage with video game players by creating quest-based programs and value new users actually value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006443167/en/ Graphic: Xsolla Video games are one of the largest categories of entertainment spending in the world, yet most brands still treat the category as an experiment: a one-off promotional stunt or a single media buy, not a lasting engagement program. The traditional formats brands default to were never built for players. Interstitial pop-ups disrupt gameplay, banner ads go unnoticed, and in-game activations remain cumbersome and expensive to execute. The idea
Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets6.10.2026 15:00:00 CEST | Press release
Europe and the Americas join Rochester's growing global e-commerce network Rochester Electronics today announced the launch of fully enabled e-commerce capabilities across its regional websites, allowing customers in key global markets to search for, source, and purchase authorized semiconductors in their local language. While Rochester's regional sites previously offered localized content and product information, they now support a complete end-to-end purchasing experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006914131/en/ Rochester Electronics Launches Localized E-Commerce Experiences Across Key Global Markets The newly upgraded platforms are now live in Portuguese (Brazil), Spanish (Mexico), French, German, Italian, and Polish, complementing Rochester’s existing full e-commerce platforms in English, Chinese, Japanese, and Korean (South Korea). Customers can now complete transactions directly through their lo
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