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
Stafford Capital Partners Announces New Renewable Energy Investment Strategy with Dedicated Team12.2.2026 09:00:00 CET | Press release
Stafford Capital Partners integrates dedicated renewables team tostrengthen the firm’s strategic infrastructure investing capabilities with a focus on energy transition opportunities. Stafford Capital Partners (“Stafford”), a leading international private markets investment and advisory firm, today announced the launch of a new strategy focused on the renewable energy sector. This initiative leverages the ongoing transformation and rapid growth within the renewables market, targeting the revamping and repowering of existing renewable assets to deliver compelling risk-adjusted returns while accelerating the transition to a low-carbon economy. This new strategic initiative further strengthens Stafford’s position in the global infrastructure investment market, providing institutions with access to a pioneering investment approach to renewable investing. This mirrors the differentiated approach Stafford has taken in developing its secondary market strategies across its real assets platform
KARL LAGERFELD Reunites With Paris Hilton for Spring – Summer 2026 “From Paris with Love” Campaign12.2.2026 08:00:00 CET | Press release
KARL LAGERFELD unveils its Spring–Summer 2026 campaign, From Paris with Love, starring cultural icon Paris Hilton for the second consecutive season. Captured through the lens of long-time brand collaborator Chris Colls at the Maison’s headquarters, 21 Rue Saint-Guillaume in Paris, the global campaign spans the KARL LAGERFELD, KARL LAGERFELD JEANS, and KARL LAGERFELD PARIS collections. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211077844/en/ KARL LAGERFELD SS26 Campaign Paris Hilton - ©Chris Colls “Shooting the campaign at 21 Rue Saint-Guillaume was incredibly inspiring,” says Paris Hilton. “Stepping into Karl’s world felt personal and true to the DNA of both Karl and the brand. It wasn’t about looking back but being present in a space where his legacy continues to evolve.” Moving through the Maison with ease and confidence, Paris Hilton brings her signature glamour and charisma to KARL LAGERFELD’s universe through pla
AB InBev Reports Full Year and Fourth Quarter 2025 Results12.2.2026 07:01:00 CET | Press release
Underlying EPS increased by 6% with continued margin expansion and free cash flow generation of 11.3 billion USD Anheuser-Busch InBev (Brussel:ABI) (BMV:ANB) (JSE:ANH) (NYSE:BUD): This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260211688662/en/ Figure 14. Terms and debt repayment schedule as of 31 December 2025 (billion USD) Regulated and inside information1 “Beer plays an important role in bringing people together and creating moments of celebration. In 2025, we executed our strategy, made disciplined capital allocation choices and delivered growth within our outlook for the year, even as we navigated a dynamic consumer environment. We exit 2025 with improved momentum and enter 2026 well positioned to engage consumers with our megabrands and an unparalleled lineup of mega platforms. Thank you to our colleagues for their ongoing commitment, hard work and passion for our business.” – Michel Doukeris, CEO, AB InBev Revenue 4Q +
Bardasz Forms Strategic Digital Alliance with GEOLOG to Accelerate Global RTOC Delivery and Digital Well Construction Solutions12.2.2026 07:00:00 CET | Press release
HighlightsBardasz and GEOLOG form an alliance to strengthen delivery of end-to-end RTOC solutions for drilling optimization and NPT mitigation.Alliance combines Bardasz’s leadership in WITSML and ETP transmission, high-speed real-time data aggregation, and Super Store technology with GEOLOG’s global operational scale and local technical workforce.As part of the alliance, GEOLOG has made a minority investment in Bardasz, providing financial flexibility to accelerate Bardasz’s product roadmap and global expansion. Bardasz Group LLC (“Bardasz”), a provider of real-time, decision-ready intelligence for well construction—including drilling, completions, and well interventions—today announced a strategic digital alliance with GEOLOG International B.V. (“GEOLOG”), a global formation evaluation, drilling, and geochemistry services provider supporting subsurface projects in more than 40 countries. The alliance is designed to accelerate Bardasz’s global growth and enhance customer delivery by le
We Are All Sculptra: First-of-its-Kind Galderma Initiative to Demonstrate How Everyone Can Benefit from Sculptra’s Regenerative Properties12.2.2026 07:00:00 CET | Press release
Galderma unveils We Are All Sculptra, a global campaign capturing the clinical performance of Sculptra® across nine diverse patient profiles and journeys, over two years1 Backed by over 25 years of clinical use, Sculptra continues to prove its versatility as a regenerative treatment that works across all three layers of the skin2-6 The campaign captures the patients’ clinical and emotional experiences – including before & after treatment imagery – highlighting Sculptra’s adaptability and reinforcing its role in tailored, science-backed regenerative aesthetic care1 Galderma (SIX: GALD), the pure-play dermatology category leader, today unveiled We Are All Sculptra, a unique program designed to capture the clinical impact of Sculptra® across nine diverse patients – who were all new to injectable aesthetics – over two years.1 This innovative initiative will offer a rare and authentic real-life perspective on the power of regenerative biostimulation to deliver personalized outcomes, and dem
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