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
Ant International Launches Industry's First Full-Stack AI-Native Solutions for Payment, Account, FX, Treasury and Growth Operations for Global Businesses18.9.2026 08:53:00 CEST | Press release
In its largest-ever product upgrade, the company unveils an industry-first AI-native, end-to-end full financial stack with close to 100 key products across 4 business pillars.Built on newly upgraded Antom 3-in-1 Transformer, our payment foundation model, and FalconTST, our AI FX & liquidity forecast model.Underpinned by an agent-ready, 2-layered trust and security framework, and a governance-by-design approach that keeps us aligned with evolving compliance and regulatory environments.Autopilots for payment, account and treasury management embedded in the end-to-end financial stack to manage the five main workstreams in natural-language interaction.Introduces agent-native solutions including world's first Account for Agent (AFA) for businesses.89.5% of clients of our main merchant payment service already deployed our FinAI solutions in past 12 months. 81.4% of payment tasks were completed with AI help. In an industry first, Ant International launched a full stack of AI-native solutions
Takeda Employees Select Four New Global Corporate Social Responsibility Collaborations to Advance Climate-Resilient Health Systems18.9.2026 07:00:00 CEST | Press release
2026 Awardees are Corus International,Humanity & Inclusion Handicap International, Kwame Nkrumah University of Science and Technology (KNUST) and Terre des hommes Foundation (Tdh)Commitment of USD 22.2 Million Increases Takeda’s Total Global CSR Program Contributions to USD 260.9 Million Across 42 Diverse Collaborations Worldwide, With 20 Currently Ongoing in 42 Countries Takeda (TSE:4502/NYSE: TAK) announced that it has awarded a total of USD 22.2 million to four new Global Corporate Social Responsibility (CSR) partners as part of the company’s ongoing commitment to supporting climate-resilient health systems in low- and middle-income countries around the world and aligned with the company’s purpose of better health for people, brighter future for the world. As climate change, extreme weather events and shifting global aid priorities continue to challenge healthcare access, Takeda is advancing its 2026 collaborations with the goal of expanding equitable access, strengthening health sy
Beacon Acquires Haize Labs to Power AI for the Real Economy17.9.2026 16:30:00 CEST | Press release
Haize Labs leadership will anchor Beacon’s new applied AI research group, accelerating the deployment of AI across the essential businesses Beacon owns Beacon Software (Beacon), the first centralized AI holding company, today announced that it has acquired Haize Labs, an AI reliability company that tests and safeguards AI agents for real-world deployment. The Haize Labs team will join Beacon to form its Applied AI Research Group, with co-founder and CEO Leonard Tang joining as VP of AI Research to lead the AI operating system that is deployed across Beacon’s companies. Beacon believes that the fastest way to bring AI to the traditional economy is through the software businesses that essential industries already use and trust, equipping them with AI infrastructure. Beacon acquires these businesses for long-term growth and connects them to a centralized AI operating system that compounds with each additional acquisition and industry. The addition of the Haize Labs team will strengthen th
TIMELAB Develops OEM/ODM Hair Straightener Reaching 200°C at All Three Measured Points in 15 Seconds17.9.2026 16:00:00 CEST | Press release
Testing at 230 V with a 260°C setting confirmed at least 200°C after 15 seconds at all three measured plate locations (front, center and rear), not just a single point. TIMELAB Co., Ltd., a Japanese beauty-appliance OEM/ODM provider, has developed a hair straightener for OEM/ODM customization for international hair care brands and professional markets. In testing at 230 V with a 260°C setting, all three measured plate locations reached at least 200°C after 15 seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914187865/en/ Three-Point Plate Testing A European-market development unit with a maximum setting of 260°C was tested at 230 V. Fifteen seconds after power-on, readings at the front, center and rear were 212.5°C, 227.5°C and 200.0°C, respectively. From around 60 seconds onward, temperature differences among the three points narrowed, indicating a stable trend. Precision Temperature Control An NTC sensor inside t
Earnix Brings Agentic AI to the Decisions That Drive Insurance Performance17.9.2026 15:09:00 CEST | Press release
Agent Hub, part of Earnix AIOS, brings more than 25, insurance-specific agents and apps into Earnix’s governed pricing, underwriting, and customer decision solutions- improving workflows and business performance Earnix today announced the introduction of Agent Hub, a curated catalog of insurance-specific AI agents and apps within Earnix AIOS — the AI Orchestration System powering Earnix’s pricing and rating, underwriting, and customer engagement solutions. Agent Hub brings agentic AI directly into these solutions, enabling more intelligent workflows and strengthening the high-stakes decisions that shape pricing, underwriting, customer engagement, growth, and profitability. In an increasingly turbulent insurance environment, the useful life of an insurance decision is getting shorter. Risk and market conditions are changing faster, making growth, profitability, and portfolio performance harder to manage. AI is increasing the speed and scope of what insurers can analyze, recommend, and i
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