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
Compass Pathways to Participate in 2026 Cantor Global Healthcare Conference on September 9, 20261.9.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that management will attend the 2026 Cantor Global Healthcare Conference on September 9, 2026 and will participate in a fireside chat at 3:20pm ET and a panel entitled “PSYCH! Accessing The New Wave of Psychedelics” at 4:30pm ET. A live audio webcast of the fireside chat will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event. About Compass Pathways We believe mental health patients deserve the possibility of a better future. Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resis
EMVCo Requests Feedback on Framework for Secure, Interoperable and Scalable Card-Based Agentic Payments1.9.2026 11:00:00 CEST | Press release
EMVCo – the technical body that creates and manages EMV® Specifications and programmes – has released a draft framework to help promote secure, interoperable and scalable card-based agentic payments. The framework provides a foundation for further industry engagement and potential specification development, with all interested stakeholders encouraged to provide their feedback on EMV® Agentic Payments – Framework for Specificationsby Wednesday 30 September. A key focus across the agentic commerce ecosystem is how to establish intent and determine that a consumer delegated authority to an AI agent to make a purchase on their behalf. Following industry input, EMVCo has focused on card-based agentic payment scenarios where intent needs to be managed over time, such as recurring purchases, cumulative budgets and post-transaction activities. These scenarios may require access to a shared intent ‘state’ that persists across multiple participants and their interactions. EMVCo has identified an
ChargePoint Accelerates European Growth Strategy with Appointment of John Saffrett as EVP and Managing Director, Europe1.9.2026 11:00:00 CEST | Press release
Saffrett brings more than 25 years of leadership experience in global mobility, fleet management, and digital transformationAppointment signals ChargePoint's commitment to accelerating European growth as the company targets increasing its European market and revenue share ChargePoint (NYSE: CHPT), a global leader in intelligent electrification and e-mobility, today announced the appointment of John Saffrett as Executive Vice President and Managing Director, Europe. In this role, Saffrett will be responsible for driving ChargePoint's growth strategy across European markets, overseeing sales, customer relationships, partnerships, and market expansion across the continent. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260901888806/en/ ChargePoint's EVP and Managing Director John Saffrett He has served as a member of the company’s Advisory Council since March 2026 and is a seasoned global mobility executive with more than 25 ye
Club Vita Launches German VitaCurves Model as Pension Risk Transfer Market Gathers Momentum1.9.2026 10:00:00 CEST | Press release
Address-based longevity model expands Club Vita's global suite of analytics to cover the UK, US, Canada, Netherlands and Germany Club Vita, an international leader in longevity data analytics, has launched a German calibration of its popular address-based longevity model, VitaCurves, further expanding its international footprint and supporting the growing pension risk transfer (PRT) market in Germany. The launch marks another milestone in Club Vita's international expansion and extends its suite of address-based mortality models, which already provides mortality insights in the UK, United States, Canada and the Netherlands. The German VitaCurvesDEU model is already being used by a leading insurer, helping to provide a more granular understanding of longevity risk across pension and insurance portfolios. VitaCurves uses granular location-based and socio-economic data to identify differences in mortality patterns between sub-populations, enabling insurers, pension funds and other stakeho
JEOL: Launch of the New Benchtop Scanning Electron Microscope “JCM-7000Plus NeoScope™”1.9.2026 09:30:00 CEST | Press release
JEOL Ltd. (President & CEO: Izumi Oi) has developed the benchtop scanning electron microscope (SEM) “JCM-7000Plus” and will begin sales on September 1, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260825564112/en/ JCM-7000Plus NeoScope™ [Development Background] Benchtop scanning electron microscopes are increasingly used in fields including electrical and electronics, automotive and machinery, steel and metals, chemical and pharmaceuticals. They are utilized not only in research and development but also in manufacturing-related applications, such as quality control and product inspection. In addition, they are adopted in educational settings at middle and high schools as well as universities. Given these diverse applications, there is growing demand for improved operational efficiency, simpler and more automated operation, and enhanced observation, analysis, and measurement performance. To meet these needs, we have e
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