AMRA Medical Secures European Medical Device Regulation Certificate for AMRA® Profiler 4, Highlighting Yet Another Regulatory Win
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
Echoworx Secures FSQS-Netherlands Certification, Strengthening Trust in Financial Data Protection16.12.2025 08:00:00 EET | Press release
Echoworx, a global leader in email and data encryption, proudly announces it has achieved Financial Services Qualification System (FSQS) registered supplier status for the Netherlands. This certification powerfully demonstrates Echoworx’s commitment to the highest standards of security and compliance. This achievement expands on the company’s existing FSQS certification for the UK and Ireland, secured in 2020. By successfully completing the rigorous qualification for the Netherlands, Echoworx reinforces its alignment with the stringent demands of the European financial market. The FSQS system, managed by Hellios, provides a single, reliable standard for vetting third-party suppliers, streamlining procurement for major banks and financial institutions. Think of FSQS as a high-security passport for technology partners. It proves a supplier has undergone an exhaustive audit of its governance, security controls, and operational processes. For Dutch financial institutions, this qualificatio
Nippon Electric Glass to Start World’s First Mass Production of Low-Carbon Pharmaceutical Glass Tubing Using an All-Electric Furnace16.12.2025 04:00:00 EET | Press release
Nippon Electric Glass Co., Ltd. (NEG)(TOKYO:5214), a global leader in specialty glass headquartered in Otsu, Japan, announced it will begin the world’s first mass production of pharmaceutical-grade glass tubing using an all-electric melting furnace. Commercial production is scheduled to start in December 2025 at its subsidiary in Selangor, Malaysia. This breakthrough introduces a new manufacturing model for pharmaceutical packaging. By combining NEG’s proprietary all-electric melting technology with renewable energy, CO2 emissions from glass tubing production can be reduced by up to 90%*1 compared with conventional fossil-fuel combustion furnaces. This positions NEG as a major supplier capable of delivering both high-performance borosilicate glass and a significantly lower carbon footprint, directly addressing global sustainability demands from pharmaceutical companies and regulators. NEG is a leading global supplier of arsenic-free, environmentally friendly borosilicate glass tubing f
Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform16.12.2025 03:00:00 EET | Press release
Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical’s HLA-G targeted exosome program. Shine-On Biomedical sponsored Esco Aster in 2023 for cGMP services, starting with high-yield exosome development using Esco Aster’s cell line platform. The technical reports of process, analytical, and formulation development, exosome drug loading, GMP engineering runs, and stability studies supported Shine-On’s IND submission. The IND was cleared by the U.S. FDA in Q1 2025. Furthermore, Esco Aster is providing technical services for exploratory exosome loading feasibility studies per Shine-On’s instruction. Shine-On Biomedical is an emerging innovator in exosome-based drug delivery. ShineOn’s proprietary product, SOB100, a HLA-G targeted exosome drug delivery carrier, has passed the U.S. FDA IND review and ongoing Phase I study, making it as a first-in-class–potential HLA-G targeted exosome platfo
Civil Air Patrol Expands Fleet With 15 New Cessna Aircraft to Support Lifesaving and Community Missions15.12.2025 18:00:00 EET | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, announced today that Civil Air Patrol (CAP), the world’s largest operator of Cessna aircraft, is strengthening its national mission capabilities with an order for 15 additional piston-engine aircraft, including seven Cessna Skyhawk 172 and eight Cessna Skylane 182 models scheduled for delivery throughout 2026. The order follows recent deliveries of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft, expanding CAP’s fleet to more than 500 Cessna aircraft nationwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215613573/en/ Delivery of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft joins CAP’s fleet of more than 500 Cessna aircraft nationwide. Cessna aircraft are designed and produced by Textron Aviation. “Civil Air Patrol’s missions demand aircraft that are reliable, versatile and ready to perform in critic
Winston & Strawn and Taylor Wessing UK to Combine, Creating a Premier Transatlantic Law Firm15.12.2025 17:52:00 EET | Press release
Winston & Strawn and Taylor Wessing’s UK-led business announced today their intention to combine, creating a premier transatlantic law firm that would operate under a new shared name, Winston Taylor. The combination responds to increasing client demand for seamlessly integrated US–UK–EU counsel for the businesses, people, and markets driving capital and innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215914957/en/ The combination once final will unite two international firms with more than 400 years of combined history, complementary strengths, and a common vision to meet clients’ evolving global needs. The combined firm will include more than 1,400 lawyers, establishing one of the largest transatlantic firms whose footprint is primarily in the United States, the United Kingdom, and Europe, and also in Latin America and the Middle East. Leveraging significant strength and scale in major litigation, critical tra
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