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
Lapmaster Wolters and Precision Surfacing Solutions Secures Strategic Minority Investment from The Cynosure Group and Fernweh Group to Accelerate Growth8.10.2026 22:49:00 CEST | Press release
Investment strengthens the balance sheet and brings long-term strategic partners to support continued growth and expansion across semiconductors, advanced materials, advanced packaging, and precision optics end markets. Lapmaster Wolters and Precision Surfacing Solutions (“Lapmaster Wolters”), a leading global supplier of high-precision machine systems and consumables to the semiconductor, advanced materials, precision optics, and advanced packaging industries, today announced the completion of a minority equity investment by affiliates of The Cynosure Group (“Cynosure”) and Fernweh Group (“Fernweh”). The investment strengthens the balance sheet and adds long-term, engaged partners to support the company’s next phase of growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261008141876/en/ Positioned for growth Demand for ultra-high-precision surface finishing continues to grow as customers in semiconductors, advanced mater
Dubai Launches Global Create AI Agents Championship with Prize Pool Exceeding AED 2.5 Million8.10.2026 19:05:00 CEST | Press release
Dubai has launched the Create AI Agents Championship, a global competition inviting innovators to develop practical and scalable AI-agent solutions that address real-world challenges, with a total prize pool exceeding AED 2.5 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261008883373/en/ Dubai has launched the Create AI Agents Championship as part of its efforts to accelerate the adoption and development of Agentic AI (Photo: AETOSWire) The launch of the championship was announced by H.H. Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, Crown Prince of Dubai, Deputy Prime Minister and Minister of Defence of the UAE, and Chairman of The Executive Council of Dubai, who encouraged innovators from around the world to participate. Led by Dubai Chamber of Digital Economy, the championship aims to accelerate the adoption of Agentic AI and support the development of innovative AI-agent solutions with strong potential for
Seiden Law LLP issues statement: Prosecuted by Press Conference: Declared Guilty Without a Charge, Yim Leak Family Asks UN Human Rights Experts to Hold Thailand to Its Own Treaty Commitments8.10.2026 18:26:00 CEST | Press release
Urgent appeal to UN Special Rapporteurs cites the presumption of innocence, due process and protection of a child. The key facts are the Thai government's own words and files. Seiden Law LLP, chief global counsel to Cambodian businessman Yim Leak, announced today that Jared Genser, international counsel to Mr. Yim and his wife, has asked two UN Special Rapporteurs to send an urgent appeal to the Thai government. The request is made on behalf of the couple and their seven-year-old son. It says Thailand violated its international human rights commitments by announcing the family’s guilt before any court had tried them, and by freezing their assets, including their minor son’s savings, without a hearing. Six Official Statements in Nine Months. No Charge Filed in Any Court. Between December 2025 and September 2026, Thai officials described Mr. Yim as the center of a criminal network on six occasions: at two press conferences chaired by the head of the Thai government, in the House of Repre
Sam Altman-Backed Meanwhile Raises $37.5M as Families Across Asia, Europe and the Middle East Turn to Bitcoin Life Insurance8.10.2026 18:12:00 CEST | Press release
Existing investors, led by Bain Capital Crypto, back the first licensed Bitcoin life insurer after its single-premium policy for international clients drives a record year Meanwhile, the first life insurer licensed to operate entirely in Bitcoin, today announced $37.5 million in new funding from its existing investors. Bain Capital Crypto led the round, alongside Haun Ventures, Framework Ventures, Pantera Capital, Apollo, Northwestern Mutual Future Ventures, and Morgan Creek Digital. Meanwhile, whose backers also include Sam Altman, has now raised more than $180 million. The round follows a surge in international demand for Meanwhile’s Bitcoin life insurance policies, particularly in Asia, Europe and the Middle East amid broader macro instability. In early 2026, Meanwhile launched BTC Life 1-Pay, a single-premium whole life policy built for high-net-worth clients outside the United States. It is the company's second product line after BTC 10-Pay, which is purposely designed for US taxp
Toluna Announces Planned CEO Transition After 25 Years; Founder Frédéric Charles Petit to remain as Board Member, Senior Advisor and Shareholder8.10.2026 16:20:00 CEST | Press release
Toluna, a global leader in consumer insights and market research technology, today announces a planned leadership transition. After 25 years leading the company he founded, Frédéric Charles Petit, Founder and Chief Executive Officer, intends to transition from his role as CEO following the appointment of his successor as part of a carefully planned succession process designed to ensure continuity for clients, employees and partners. Following the transition, Mr. Petit will continue to serve on Toluna's Board of Directors, will remain a significant shareholder of the company, and will take on an ongoing strategic advisory role for areas central to Toluna's next phase of growth. The Board, in close consultation with Mr. Petit, has initiated a structured succession process. A comprehensive transition plan is in place, including a defined handover with Mr. Petit, to ensure continuity for the company’s clients, employees, and partners. The Board expects to confirm the appointment of the com
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