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
Altasciences Completes Expansion of Research and Development Laboratory in Harleysville, Pennsylvania4.8.2026 14:00:00 CEST | Press release
Altasciences is excited to share it has expanded the R&D laboratory at its drug product formulation and manufacturing services facility in Harleysville, Pennsylvania, adding approximately 768 square feet of new laboratory space. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804164599/en/ From left to right: Nasir Egal (General Manager, CDMO Services); Marie-Hélène Raigneau (Chief Executive Officer); Anuji Abraham (Senior Director, Pharmaceutical Development, CDMO Services); Robert Sabelli (Co-Chief Operating Officer); Cathy Konidas (Chief Administrative Officer) The expansion brings together formulation development and analytical testing within a single laboratory. This integrated setup is designed to accelerate decision-making, streamline workflows, and strengthen collaboration across scientific disciplines. “With this expansion, we are strengthening our focus on early-stage integration, bringing our CDMO capabilities t
Vasion® is Imprivata®-Ready Certified to Bring Trusted Identity Across Healthcare Print Infrastructure4.8.2026 14:00:00 CEST | Press release
New integration brings Imprivata Enterprise Access Management directly into the Vasion Platform: closing the identity gap at the print layer, enabling clinicians and healthcare users to securely release jobs at any printer with a single badge tap. Vasion, a leader in intelligent print automation, today announced a strategic integration with Imprivata, a leading digital identity and access management company for life- and mission-critical industries, starting with healthcare. The Vasion platform, with PrinterLogic®, PrinterLogic Output, and Vasion Automate, offers shared Imprivata customers a unified identity layer, spanning endpoints and printers, for secure, enterprise-wide visibility into every print job. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804404337/en/ The integration is designed to maximize existing Imprivata deployments. No rip-and-replace is required. The Vasion platform works with the Imprivata infrastr
Thredd and Pliant Expand Partnership to Launch U.S. Commercial Credit Program, Accelerate Embedded Finance for Businesses4.8.2026 14:00:00 CEST | Press release
Partnership enables cross-border expansion with a scalable, API-driven commercial credit and reconciliation platform built for speed to market Thredd, the AI-first issuer processing platform, today announced the expansion of its partnership with Pliant, bringing the company’s commercial credit and embedded finance platform capabilities to the U.S. market for the first time. Pliant provides European businesses with physical and virtual credit cards that have built-in reconciliation, spend controls, and deep integrations into modern finance stacks. Through its expanded partnership with Thredd, Pliant has successfully mirrored its established European proposition in the U.S., enabling American businesses to issue commercial credit cards that maintain real-time visibility into spend and cash-flow management. The program is live in the U.S. on the Visa network, with bank sponsorship provided by Coastal. The launch follows a successful soft rollout in late 2025, allowing Pliant to begin onbo
Techtronic Industries Delivers Strong First Half Performance4.8.2026 13:20:00 CEST | Press release
Growing Sales to US$8.3 Billion, Net Profit Increased to US$738 Million Techtronic Industries Co. Ltd. (“TTI” or the “Group”) (stock code: HK: 0669, ADR symbol: TTNDY), a global cordless power tool, outdoor power equipment and floorcare & cleaning company, is pleased to announce its results for the six-month period ended June 30, 2026. The Group delivered record first half results in 2026, with revenue growing 5.9% to US$8.3 billion. Its two leading brands, MILWAUKEE and RYOBI, both delivered a strong performance in the first half of 2026, growing at a combined 8.2% underlying growth rate in local currency. TTI delivered record first half results in 2026, with revenue growing 5.9% to US$8.3 billion and net profit increasing 17.5% to US$738 million. Our global MILWAUKEE business grew 10.5% on an underlying basis in local currency, after adjusting for the planned 2025 timing impact related to the MILWAUKEE Americas ERP system conversion. RYOBI, the #1 global consumer cordless tool and ou
WHOOP Expands Commitment to Women's Health by Including One-Year Subscription of Natural Cycles° App in Membership4.8.2026 11:00:00 CEST | Press release
The integration gives eligible WHOOP members seamless access to the only FDA-cleared hormone-free birth control app, with the first year of Natural Cycles° included for those new to the app as part of their WHOOP membership. WHOOP, the human performance company, today announced an expansion of its women’s health offering through an integration with Natural Cycles° (NC°), the only FDA-cleared, hormone-free birth control app. WHOOP is offering a 12-month subscription to the NC° app to eligible new Natural Cycles users. Members with compatible WHOOP devices can now automatically share overnight skin temperature with the NC° app to enable personalized fertility insights and hormone-free birth control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804399367/en/ WHOOP Expands Commitment to Women's Health by Including One-Year Subscription of Natural Cycles° App in Membership The Natural Cycles app, a Class II medical device, u
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