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
Around 500 Attend Sino-European ESG Conference in Germany1.7.2026 18:00:00 CEST | Press release
Around 500 government officials, business executives and academics from China and Europe gathered in the western German city of Mainz on Friday for the Third Sino-European Corporate ESG Best Practice Conference to discuss how deeper cooperation can support sustainable economic growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701255421/en/ Group photo of selected attendees at the conference. Hosted by the Chinese Consulate General in Frankfurt and jointly organized with authorities from Germany and China, the conference brought together participants from China, Germany, France, Italy, the Netherlands, Denmark, Luxembourg and several other countries under the theme "From Vision to Practice: Empowering Sustainable Growth Through Collaboration." Francesco La Camera, Director-General of the International Renewable Energy Agency (IRENA), delivered a video address. Speaking at the opening ceremony, Huang Yiyang, Chinese Co
Sinopec Receives CSR Award at Sino-European ESG Conference in Germany1.7.2026 15:38:00 CEST | Press release
China Petroleum & Chemical Corp. (Sinopec) has received the Corporate Social Responsibility Best Practice Award at the 3rd Sino-European Corporate ESG Best Practice Conference in Mainz, Germany, for its case study on carbon footprint management and low-carbon development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701696760/en/ Huang Yiyang (L), Chinese Consul General in Frankfurt, presents the award to a representative of Sinopec. The conference jury said Sinopec has developed a carbon management framework centered on product carbon footprint management, covering the full product life cycle while aligning with both Chinese and European standards. It cited the company’s work with German chemical producer BASF to achieve mutual recognition of carbon footprint accounting methodologies as a milestone that could support greener cooperation across international industrial supply chains. According to the jury, Sinopec’s eff
Vercel and Mercedes-AMG PETRONAS Formula One Team Announce Multi-Year Strategic Partnership1.7.2026 15:30:00 CEST | Press release
The agentic infrastructure platform known for speed is joining forces with one of the world's fastest Formula One teams Today Vercel, the agentic infrastructure company, announced a new multi-year deal with the Mercedes-AMG PETRONAS Formula One Team. Starting with the British Grand Prix July 2 – 5 2026, Vercel branding will appear on the Mercedes-AMG PETRONAS Formula One Team race cars as the partnership begins its first chapter, before expanding significantly across the team ecosystem from 2027 onward. The partnership includes global branding rights, premium hospitality experiences, customer engagement, content creation, and technical collaborations, including plans to evolve the team’s digital platforms to Vercel. “Formula One is where every millisecond matters, every decision counts, and continuous innovation is fundamental to success. Vercel shares that same philosophy,” said Richard Sanders, Chief Commercial Officer, Mercedes-AMG PETRONAS Formula One Team. “The Vercel platform is
OXMIQ Raises $35 Million to Scale OxCore™ Architecture1.7.2026 15:15:00 CEST | Press release
OXMIQ Labs Inc., a unified GPU and AI architecture company founded by Raja Koduri, today closed its $35 million Series A financing, bringing the company’s total capital raised to $60 million. The funding will scale OxCore™, OXMIQ’s licensable GPU architecture that allows semiconductor companies and AI system builders to build custom AI silicon without a full chip program. The round was co-led by Fundomo and Samsung Catalyst Fund, with participation from MediaTek, AM Intelligence Labs, Pegatron Venture Capital, CDIB-TEN, Darwin Ventures, and Morgan Creek Digital, among other financial and strategic investors. OXMIQ’s expertise spans the full AI stack, from renewable power and data center infrastructure to silicon IP, electron-to-token machines (ETMs™), along with the software that runs AI factories and agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701241910/en/ OXMIQ Funding raised to date of $60M after current $3
SamanTree Medical’s Histolog® Scanner Technology Featured in 13 Publications in Special BJU International Issue on Confocal Microscopy in Urology1.7.2026 15:01:00 CEST | Press release
Papers highlight clinical research on use of confocal microscopy for real-time tissue assessment in various urologic procedures SamanTree Medical, a global leader in surgical imaging innovation, today announced that Histolog Scanner confocal microscopy technology has been featured in 13 peer-reviewed clinical papers in a special issue of BJU International, one of the world’s leading journals in urology. The special edition focuses on a growing body of evidence of the role of confocal microscopy in urologic surgery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701425845/en/ SamanTree Medical announces that Histolog® Scanner confocal microscopy technology is featured in 13 peer-reviewed clinical papers in a special issue of BJU International. “The special issue represents increasing momentum behind confocal microscopy in urologic surgery,” said Professor Greg Shaw, consultant urologic surgeon at University College London
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