AMRA-MEDICAL
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 Establishes Timberland Continuation Fund at USD 1.2 billion4.12.2025 10:53:00 CET | Press release
This marks Stafford’s second timberland fund at over USD 1 Billion in 2025, backed by strong existing investor support and new capital commitments from global institutional investors Stafford Capital Partners (“Stafford”) today announced it has established a USD 1.2 billion continuation vehicle, the Stafford International Timberland Continuation Fund (The Continuation Fund or The Fund), marking a significant milestone in the firm’s strategic management of its timberland holdings. The Continuation Fund is a "roll-up" of three of Stafford’s existing core timberland funds – Stafford International Timberland funds VI, VII and VIII – into a new perpetual fund that will hold 74 high-quality core timberland assets. The fully-deployed portfolio took Stafford seven years to construct and holds interests in over 6.3m acres of commercial timberland in the USA, New Zealand, Australia and Latin America. This includes a number of assets that are seen as key strategic holdings in these regions where
Smartstream Introduces Agentic AI ‘Smart Agents’ for Investigations and Exceptions Handling4.12.2025 09:55:00 CET | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces the preview of Smart Agents for Investigations, a breakthrough in financial operations that brings augmented and autonomous exception handling to reconciliations and back-office processes. The new investigation agent combines domain-trained AI agents, workflow adoption, and embedded controls to triage, investigate, resolve, and learn from exceptions - reducing manual effort, accelerating time to resolution, and strengthening auditability. It will add a layer of intelligence on top of Smartstream’s current reconciliations and exceptions solutions. It understands the breaks context, adheres to customer playbooks and reaches out for missing information. It documents every step for audit and compliance, allowing analysts to focus on risk. Finally, it augments the analyst’s investigation with contextual information radically changing the user experience to review and a
LabGenius Therapeutics Announces New Collaboration with Sanofi for Multiple AI/ML-driven Antibody Optimisation Programmes4.12.2025 09:00:00 CET | Press release
The companies have entered into a new collaboration where LabGenius Therapeutics will apply its ML-driven antibody discovery platform (EVA™) to optimise potential therapeutic NANOBODY® proteins for multiple new targets LabGenius Therapeutics (“LabGenius”), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise potential therapeutic antibodies, today announced a second collaboration with Sanofi. This collaboration combines LabGenius’ AI/ML-driven antibody design capabilities with Sanofi’s expertise in the development of therapeutic NANOBODY® molecules to co-optimise proteins for therapeutically valuable properties. Following the success of their first collaboration, LabGenius will apply the EVA™ platform to optimise NANOBODY® molecules for multiple new targets in the area of inflammation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204759388/en/ “We are truly excited abo
GoWit One: The Unified AI Operating System Set to Revolutionize Commerce & Retail Media4.12.2025 07:09:00 CET | Press release
WPP Turkey has been selected as a pilot partner to deploy GoWit One, cutting campaign setup time to 10 minutes. GoWit, a global AdTech leader in omnichannel Commerce and Retail Media, announced the launch of GoWit One, the unified AI operating system that brings automation, unification, and real-time intelligence into a single ad platform for agencies operating across multiple retailers, channels, and markets. By bringing these three elements into one dashboard, GoWit One addresses the industry's most critical bottleneck: operational inefficiency. The platform enables agencies to manage campaigns across multiple retailers, channels, and markets, reducing manual AdOps workflows by 98%, turning a process that used to take hours into as little as 10 minutes. Solving the “Fragmentation Crisis” Despite the explosive growth of Retail Media, the industry faces a significant hurdle. According to the IAB, 70% of the market still lacks end-to-end AI adoption. Media buyers are currently forced to
Galderma Secures ‘BBB’ Credit Rating With Positive Outlook from S&P Global Ratings4.12.2025 07:00:00 CET | Press release
‘BBB’ long-term issuer credit rating from S&P Global RatingsPositive outlook, reflecting expected profitability improvement, ramp up of Nemluvio, and continued deleveraging and balance sheet improvementRecognition of Galderma’s science-based dermatology portfolio and global operations Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that S&P Global Ratings (S&P) has assigned the company a ‘BBB’ long-term issuer credit rating with a positive outlook. The rating reflects Galderma’s strong track record of growth and its leading positions across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. S&P notes the company’s well-established brand portfolio, global footprint, including an expanding presence in emerging markets, and continued investment in science-based innovation. S&P highlights momentum from recent launches, including Nemluvio® (nemolizumab), alongside improving profitability and expanding free operating cash flow
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