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
Mobix Labs Signs Definitive Agreement to Acquire Vision Aerial, Accelerating Global Drone Platform for National Security and Aerial Intelligence24.7.2026 14:00:00 EEST | Press release
Mobix Labs, Inc. (Nasdaq: MOBX) today announced that it has signed a definitive agreement to acquire Vision Aerial, Inc., a U.S.-based designer and manufacturer of American-built, National Defense Authorization Act (NDAA)-compliant unmanned aerial systems. The definitive agreement moves the transaction beyond the previously announced letter of intent and represents a major step toward closing an acquisition that would expand Mobix Labs into one of the world’s most important technology growth markets: secure drones, autonomous aerial systems and aerial intelligence for national security, critical infrastructure, energy, public safety, industrial inspection and government operations. Vision Aerial’s customers and end-users include the U.S. Air Force, U.S. Navy, government agencies, energy and utility operators, research institutions and other organizations requiring performance, reliability and trusted supply chains. Its drones support national security and public-safety operations, sear
Enhertu ® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer24.7.2026 14:00:00 EEST | Press release
Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from theDESTINY-Breast09 phase 3 trialpresented at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In DESTI
SLB Announces Second-Quarter 2026 Results24.7.2026 13:50:00 EEST | Press release
SLB (NYSE: SLB) today announced results for the second-quarter 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722694386/en/ The exterior of the SLB headquarters in Houston, Texas. Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2026Mar. 31, 2026Jun. 30, 2025SequentialYear-on-yearRevenue $8,972 $8,721 $8,546 3% 5% Income before taxes - GAAP basis $1,018 $956 $1,285 6% -21% Income before taxes margin - GAAP basis 11.3% 11.0% 15.0% 38 bps -369 bps Net income attributable to SLB - GAAP basis $786 $752 $1,014 5% -22% Diluted EPS - GAAP basis $0.52 $0.50 $0.74 4% -30% Adjusted EBITDA* $1,899 $1,773 $2,051 7% -7% Adjusted EBITDA margin* 21.2% 20.3% 24.0% 83 bps -284 bps Pretax segment operating income* $1,404 $1,321 $1,584 6% -11% Pretax segment operating margin* 15.6% 15.2% 18.5% 49 bps -289 bps Net income attributable to SLB, excluding charges & credits* $833 $783 $1,0
NIQ Expands GenAI Capabilities Across gfknewron, Turning Trusted Intelligence into Decisions Faster24.7.2026 13:30:00 EEST | Press release
NIQ (NYSE: NIQ), a leader in consumer intelligence, today announced the expansion of AI-powered Smart Insights across its gfknewron® platform. By bringing together markets and categories into a single view, gfknewron enables businesses to transform complex market, consumer and supply chain data into clear, actionable intelligence quickly. The latest enhancements help users identify trends, opportunities and performance drivers more quickly, reducing the time required to analyze large datasets and accelerating confident decision-making across teams. As brands and retailers face growing pressure to respond quickly to changing consumer behavior and market dynamics, the ability to unlock meaningful insights from increasingly rich datasets has become a significant competitive advantage. As AI is only as effective as the intelligence behind it, Smart Insights helps businesses realize the full value of NIQ's trusted market intelligence by automatically surfacing the trends, opportunities and
Thales to Strengthen Romania’s Airspace Protection With Twelve Ground Master 200 MM/A Radars24.7.2026 11:05:00 EEST | Press release
In a context of growing collaboration between European nations to bolster collective security, the Romanian General Directorate for Armaments has just signed a landmark agreement with France’s Direction Générale de l’Armement (DGA) to acquire twelve Thales Ground Master 200 Multi-Mission All-in-one (GM200 MM/A) radars. This government-to-government agreement, funded under the European Union’s SAFE programme, underlines the high level of partnership between France and Romania. The first delivery is expected in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260724603527/en/ The Romanian General Directorate for Armaments and the French Direction Générale de l’Armement (DGA – the French defence procurement agency) have signed an agreement to supply twelve Thales GM200 Multi-Mission All-in-one (GM200MM/A) radars to protect the Romanian airspace. The GM200 MM/A is a combat-proven medium-range 4D AESA radar, already deployed
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