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
Yubico Reveals 265% ROI and 99.99% Reduction in Risk of Exposure to Addressable Breach Risk Costs According to Total Economic Impact Study3.2.2026 15:00:00 CET | Press release
Effectiveness of Yubico’s technology: $5.3 million Net Present Value and $7.3 million in total benefits over three years, driven by 80% faster authentication and reduced help desk burden Yubico (NASDAQ STOCKHOLM: YUBICO), a modern cybersecurity company and creator of the most secure passkeys, today announced the results of a commissioned Total Economic Impact™ (TEI) of Yubico YubiKeys study conducted by Forrester Consulting. The study, comprised of interviews with global enterprises with over 5,000 employees, found that a composite organization based on interviewed customers achieved a 265% return on investment (ROI) and a net present value (NPV) of $5.3 million over three years by replacing traditional multi-factor authentication (MFA) and one-time passwords (OTPs) with phishing-resistant YubiKeys. In an era of high-quality deepfakes and generative AI-driven extortion, the study shows a critical shift in cybersecurity: traditional MFA is no longer sufficient to stop modern MFA-bypass
Fitch Solutions Delivers AI-Ready Credit Data on Snowflake Marketplace3.2.2026 15:00:00 CET | Press release
Direct access to Fitch Ratings and dv01 datasets now available on Snowflake Marketplace to accelerate financial modeling Fitch Solutions, a leading global provider of insights, data, and analytics, today announced a collaboration with Snowflake, the AI Data Cloud company, to deliver Fitch’s comprehensive datasets on Snowflake Marketplace. This offering will enable market participants and clients to access and work with Fitch’s credit intelligence directly within Snowflake, supporting faster analysis and simpler integration across modern workflows. Fitch Ratings credit data and loan-level performance benchmark datasets from dv01, a Fitch Solutions company, covering the U.S. auto, consumer unsecured, and non-agency RMBS sectors, are now available on Snowflake Marketplace. Additional offerings will follow, including data from Sustainable Fitch, CreditSights, and BMI. Over time, this will enable clients to access all of Fitch Solutions' universe directly in Snowflake. “Data sits at the hea
SLB Awarded Integrated Development Contract for Mutriba Field in Kuwait3.2.2026 15:00:00 CET | Press release
Kuwait Oil Company awards SLB five-year contract for next stage of Mutriba field development Global technology company SLB (NYSE: SLB) today announced that Kuwait Oil Company has awarded SLB a $1.5 billion, five-year integrated contract for the Mutriba field in Kuwait, including design, development and production management. The work builds on SLB’s subsurface understanding of the Mutriba field to support development planning and execution across deeper, technically demanding reservoir conditions. The contract covers development of high-pressure, high-temperature reservoirs with sour conditions, reflecting an expanded scope and responsibility for SLB as work on the Mutriba field progresses. “This award reflects the strength of our long-standing partnership with Kuwait Oil Company and the trust built over decades of working together,” said Steve Gassen, executive vice president, Geographies, SLB. “As development of the Mutriba field moves into its next stage, we are taking on end-to-end
LF Chooses Rimini Street to Optimize ERP Support, Drive Innovation and Transform the Business3.2.2026 15:00:00 CET | Press release
Leading South Korean lifestyle brand turns to Rimini Support™ for its Oracle and SAP enterprise systems to achieve cost savings, improve quality and responsiveness and fund innovation 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 that LF, a leading lifestyle company in South Korea, has selected Rimini Support™ to optimize maintenance for SAP ECC 6.0 and Oracle Database systems. With Rimini Street, LF is enhancing operational stability and accelerating business innovation projects, leveraging cost savings achieved to fuel transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203604473/en/ LF Chooses Rimini Street to Optimize ERP Support, Drive Innovation and Transform the Business LF’s Journey to Premium Support for Less Founded in 1974, LF is a leader in South Korea’s fashion
CSG Helps Businesses Cut Fraud Losses by Up to 70% with CSG Payments Protection.ai3.2.2026 14:30:00 CET | Press release
AI-powered fraud detection solution enables near-real-time, cross-channel transaction monitoring to stop fraud without slowing legitimate payments As payments fraud accelerates with AI, businesses are racing to spot and block threats without slowing customers down. Today, CSG® (NASDAQ: CSGS) launched CSG Payments Protection.ai, a next-generation fraud detection and financial risk management solution to accurately identify and stop payment fraud. The solution proactively monitors digital transactions across diverse payment channels and fraud types, so businesses can reduce fraud losses by 50–70% while significantly lowering false-positive alerts and the resulting customer friction. “Fraud is no longer a once-in-a-while surprise,” said Saurabh Joshi, EVP and President, CSG Payments. “It’s constant, adaptive, and affects businesses regardless of size or industry. That’s why it was so important for us to offer an always‑learning AI solution that can help businesses stay ahead of increasing
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