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
Bureau Veritas:Sector-Leading Organic Revenue Growth of 6.5% in FY 202525.2.2026 07:30:00 CET | Press release
Strong margin improvement to 16.3% in FY 2025Positive growth outlook with continued margin expansion in 2026New EUR 200 million share buyback Bureau Veritas (BOURSE:BVI): 2025 key figures1 › Full-year revenue of EUR 6,466.4 million, up 6.5% organically (with 6.3% organic growth in Q4). At constant currency, the growth was up 7.3% year-on-year and up 3.6% on a reported basis, › Adjusted operating profit of EUR 1,052.9 million, up 5.7% versus EUR 996.2 million in FY 2024, representing an adjusted operating margin of 16.3%, up 32 basis points year-on-year and up 51 basis points at constant currency, › Operating profit of EUR 992.4 million, up 6.3% versus EUR 933.4 million in FY 2024, › Adjusted net profit of EUR 631.4 million, up 1.7% versus EUR 620.7 million in FY 2024, › Adjusted EPS stood at EUR 1.42 in 2025, with a 2.8% increase versus FY 2024 (EUR 1.38 per share) and up 9.2% at constant currency, › Attributable net profit of EUR 588.0 million, up 3.3% versus EUR 569.4 million in FY 2
Galderma Announces Triple Approval of New State-of-the-Art Restylane® Syringe in the EU, the U.S., and Canada, Reaffirming the Company’s Position at the Forefront of Injectable Aesthetics25.2.2026 07:00:00 CET | Press release
Regulatory authorities in the European Union (EU), the United States (U.S.), and Canada have approved a new state-of-the-art Restylane®syringe for use with a range of Restylane NASHA® lidocaine products in multiple indications in the face and in the hands1-3 Developed in collaboration with aesthetic practitioners, its innovative ergonomic design features a cushioned finger grip and thumb rest, to improve practitioner experience through better injection comfort and control, helping them deliver consistently premium results 4-7 The syringe’s carton packaging is the first in the industry to be made from 100% recyclable paper, and reaffirms Galderma’s commitment to sustainability and environmental responsibility 8 These approvals demonstrate Galderma’s strong heritage in Injectable Aesthetics, and its commitment to continuing to drive innovation in the field Galderma (SIX: GALD), today announced that regulatory authorities in the EU, the U.S., and Canada have approved a new state-of-the-ar
Azafaros Announces Publication of Preclinical Efficacy Data with Nizubaglustat in GM2 Gangliosidosis25.2.2026 07:00:00 CET | Press release
Preclinical proof-of-concept data in GM2 gangliosidosis demonstrated survival benefit, functional improvement and target engagementResults are published in the 7 January issue of the Journal of Inherited Metabolic DiseaseNizubaglustat is currently in Phase 3 registrational studies in GM1/GM2 gangliosidoses and Niemann-Pick type C disease (NPC) Azafaros, a company aiming to become a leader in lysosomal storage disorders (LSDs), focused on addressing especially neurological symptoms, today announced the publication of proof-of-concept preclinical data with its lead product, nizubaglustat, in GM2 gangliosidosis. The data, published in the 7 January issue of the Journal of Inherited Metabolic Disease in collaboration with the laboratory of Dr. Jagdeep Walia, Department of Pediatrics, Queen's University, Kingston, Canada, reinforce nizubaglustat’s potential to address unmet needs in rare LSDs and build on existing preclinical and clinical evidence. The preclinical study tested nizubaglustat
Verdict Expected Soon in Klarna’s $8.3 Billion Antitrust Lawsuit Against Google24.2.2026 19:09:00 CET | Press release
PriceRunner v. Google: Sweden’s Largest-Ever Civil Damages Claim Reaches Decision Stage; Klarna Provides Investor Update Klarna Group plc (NYSE: KLAR) announces that the Patent and Market Court of Sweden (Patent- och marknadsdomstolen) is expected to deliver its verdict on April 15, 2026 in the antitrust damages proceedings brought by Klarna’s subsidiary PriceRunner International AB against Google LLC and Google Ireland Limited. The trial, which ran from October 20 to December 19, 2025, concerned PriceRunner’s claim for approximately $8.3 billion in damages — the largest civil damages claim ever filed in a Swedish court. The Case The claim arises from Google’s abuse of dominance in online comparison shopping, as established by the European Commission in a binding 2017 decision and upheld without reservation by the Court of Justice of the European Union in September 2024. PriceRunner alleges that Google systematically demoted competing price comparison services in its search results whi
INRIX Announces New Generation of AI Traffic Products: Helping to Improve Safety, Reduce Congestion, and Enhance Mobility Operations24.2.2026 16:49:00 CET | Press release
New generative AI capabilities, enhanced incident detection, and expanded customer deployments mark a major evolution of the INRIX Traffic product family INRIX, a global leader in transportation data and analytics, today announced a major expansion of its Trafficfamily of products, delivering innovativeAI-driven capabilities to help transportation agencies and logistics organizations move from reactive traffic management to proactive, safety-focused and efficient operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260224267928/en/ INRIX introduces expanded automation, generative AI capabilities, enhanced incident detection, and continuous analytics. Over twenty years ago, INRIX commercialized the first system to use GPS data to create real-time traffic information. In 2019, INRIX launched AI Traffic – the world's first traffic platform to leverage deep learning models and AI to improve the quality and analysis globall
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