AMRA Medical Secures European Medical Device Regulation Certificate for AMRA® Profiler 4, Highlighting Yet Another Regulatory Win
29.8.2024 16:55:00 EEST | 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.
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
Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting20.3.2026 16:00:00 EET | Press release
Incyte (Nasdaq:INCY) today announced that data from key programs in its Inflammation and Autoimmunity (IAI) franchise will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting, to be held March 27 – 31, 2026, in Denver. “At AAD 2026, we are presenting late‑breaking 54-week results from the Phase 3 STOP‑HS program evaluating povorcitinib in hidradenitis suppurativa (HS),” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. “These data provide longer term evidence of the safety and efficacy of povorcitinib in HS patients and further strengthen the significant growth potential of our Inflammation and Autoimmunity franchise.” Details on key data presentations at AAD include: Late-Breaking Oral Presentations Hidradenitis Suppurativa Povorcitinib in Patients With Moderate to Severe Hidradenitis Suppurativa: 54-Week Efficacy and Safety Results From the STOP-HS1 & STOP-HS2 Phase 3 Studies (Session: S034 – Late-Breaking Research: Sess
MUSASHI JAPAN by TAIMATSU Launches “Road to Shogun” – A Journey Through Craftsmanship and Discovery20.3.2026 14:58:00 EET | Press release
Musashi Japan by TAIMATSU Co., Ltd., a contemporary Japanese knife brand rooted in the spirit of craftsmanship and cultural harmony, has announced its newest experiential campaign: “Road to Shogun.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320887471/en/ Designed as the brand’s most ambitious customer journey to date, the campaign invites visitors to explore participating Musashi Japan stores while discovering the traditions, culture and craftsmanship that inspire the brand. Inspired by the journey towards mastery, the experience encourages participants to progress through a series of ranks whilst visiting stores and unlocking rewards that celebrate elements of everyday Japanese culture. At Musashi Japan, craftsmanship is not only about the final product, but also about the path taken to achieve mastery. The Road to Shogun reflects this philosophy by guiding customers through a journey that mirrors the dedication, cu
Futur Delivers Strong Growth and Record Profit in 202520.3.2026 13:05:00 EET | Press release
"2025 was a record year for Futur. In a market characterized by sharp market fluctuations, Futur continued to invest, grow and deliver strong results. Behind this record performance is stable customer growth, strong inflows and cost discipline. Our close cooperation with over 60 partners gives customers the freedom to choose the asset management and advisory services that best suit them. The strategy of letting the customer choose is appreciated, which is reflected in us welcoming more than 21,000 new customers during the year", says Torgny Johansson, CEO of Futur. "We are optimistic about the future. Futur has great opportunities to continue growing in the coming years by developing innovative and efficient services for savings and pensions. I am proud of how all employees have purposefully embraced our strategy and continue to work towards the goal of reaching 500 billion kronor in savings capital with the current organization", concludes Torgny Johansson, CEO of Futur. Key highlight
Lyten to Establish a Lyten Industrial Hub in Poland20.3.2026 13:00:00 EET | Press release
Lyten, the supermaterial applications company and global leader in an energy storage, has announced its interest in establishing a Lyten Industrial Hub in Poland. In 2026, Lyten will conduct a feasibility study to assess manufacturing requirements for Lyten products, potential private and public partnerships, and the necessary energy and utility infrastructure. The industrial hub will be built around Lyten Dwa – the energy storage production plant and R&D center in Gdańsk. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320045026/en/ Lyten Voltpack Mobile System in front of Lyten Dwa plant in Gdansk, Poland In February 2026, Lyten announced the establishment of its first Industrial Hub in Skellefteå, Sweden, on the site of the former Northvolt Ett plant, which it recently acquired. It will combine battery production with a data center with a capacity of up to 1 GW, being built by EdgeConneX. Once it reaches full production
PUMA Reveals Its Most Powerful International Football Kit Lineup yet on the Streets of New York City20.3.2026 09:00:00 EET | Press release
Global sports company PUMA unveiled its new national team kits for 11 nations with a street-level event at Domino Square in New York City, that placed football, music, food, and culture at the center stage in a celebration of the game. Rather than launching in a stadium setting or in a cinematic brand film, PUMA chose to reveal the kits in play, worn first by local community players from each nation on the streets of New York. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320641449/en/ Reinforcing its status as a leading force in football kits at this summer’s competition, PUMA unveiled jerseys for 11 nations, including the most prominent African partner federations of any brand in the tournament, in a community-first celebration of football, music, and culture in New York City. Four continents are united under 11 nations: Portugal, Morocco, Ghana, Paraguay, Senegal, Côte d’Ivoire, Czech Republic, Switzerland, New Zealan
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