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
Axelspace’s Seven GRUS-3 Earth Observation Microsatellites Successfully Launched and First Signals Received8.7.2026 07:00:00 CEST | Press release
Axelspace Corporation (“Axelspace”), a leading developer and operator of microsatellites dedicated to realizing its vision of “Space within Your Reach,” announced that the seven GRUS-3 next-generation Earth observation microsatellites were successfully launched and that the first radio signals were successfully received. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707291751/en/ The successful launch of Falcon 9 ©SpaceX GRUS-3 was integrated via Exolaunch and launched aboard a SpaceX Falcon 9 rocket from Vandenberg Space Force Base in California, USA, on July 7, 2026 at 07:12 (UTC) during the Transporter-17 rideshare mission. The satellites were successfully put into their intended orbit. Axelspace received the first radio signals from all the seven satellites in orbit. The satellites are currently operating normally. Axelspace is working toward completing the critical operation of the GRUS-3 microsatellite to ensure pr
QpiAI Open-Sources Its Quantum SDK to Accelerate Global Quantum Software Development8.7.2026 06:30:00 CEST | Press release
QpiAI, a globally leading full-stack quantum computing company, today released the QpiAI Quantum SDK as open-source software. Available now at https://github.com/qpiai/quantum-sdk, the QpiAI Quantum SDK gives developers, researchers, and startups an accessible, developer-friendly toolkit to build and run quantum algorithms and to connect their quantum development workflows directly to QpiAI's 8-qubit and 25-qubit quantum computers through QpiAI-QCloud (https://qcloud.qpiai.tech/). The release is designed to expand access to quantum software development for developers, researchers, universities, startups, and enterprise innovation teams worldwide. By open-sourcing the SDK, QpiAI is giving the global quantum community a practical foundation for building industry-specific quantum solutions across finance, logistics, materials, chemistry, security, AI, optimization, and advanced scientific computing. The QpiAI Quantum SDK provides a Python-based interface for circuit creation, simulation,
Access Advance Welcomes Wave of New Licensees to the HEVC Advance Patent Pool8.7.2026 02:00:00 CEST | Press release
Access Advance LLC, the leading HEVC patent pool administrator, today announced a significant expansion of the HEVC Advance Patent Pool, with 28 companies executing licenses in the first half of 2026. The new Licensees span consumer electronics, automotive, telecommunications, industrial technology, and professional security, reflecting the breadth of industries in which HEVC has become a foundational video technology. "HEVC remains the cornerstone of modern video delivery, and the demand we are seeing from new Licensees speaks to the long-term commercial relevance of this technology," said Peter Moller, CEO of Access Advance. "HEVC licensing activity has been consistently strong, and we are pleased to welcome a number of important new participants to the program." Notably, nine video surveillance equipment manufacturers have joined the HEVC Advance program as Licensees, ranging from three of the world's largest video surveillance equipment makers to specialized developers of security
Empire State Building Observation Deck Run-Up Returns for 48th Annual Race on Oct. 68.7.2026 00:22:00 CEST | Press release
Presented by NYU Langone Health and Powered by MerrellLottery Open Through July 20 The Empire State Building Observation Deck (ESB), atop the “World’s Most Famous Building,” today announced that general lottery registration is open for this year's Empire State Building Observation Deck Run-Up (ESBRU), which will run through July 20, 2026. The annual race, presented by NYU Langone Health and powered by Merrell, will take place on Oct. 6, 2026, at 8 p.m. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707902561/en/ Empire State Building Observation Deck Run-Up Returns for 48th Annual Race on Oct. 6 This year’s race marks the 48th anniversary of the event, in which 225 runners will race up 1,576 stairs of the iconic New York City landmark to reach the world-famous 86th Floor Observation Deck. “Every year, the Empire State Building Observation Deck Run-Up is a remarkable feat for all who participate as they race up to Tripadvi
Modon's Hudayriyat Golf Estates Sets UAE Record With More Than AED 13 Billion in Sales Within Days of Launch7.7.2026 20:36:00 CEST | Press release
A record-breaking sales value for a residential project in the UAEThe project comprises golf mansions, villas, and townhouses across Hudayriyat Island, Abu Dhabi1,700 residences sold within days after the launch15% non-UAE resident buyers81% new customers to Modon Modon has set a new benchmark for the UAE real estate market with the launch of Hudayriyat Golf Estates on Hudayriyat Island, Abu Dhabi. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707126559/en/ Modon's Hudayriyat Golf Estates sets UAE record with more than AED 13 billion in sales within days of launch (Photo: AETOSWire) Within days of launch, the community achieved record-breaking sales exceeding AED 13 billion, marking the highest publicly recorded sales value for a single residential project launch in the UAE. Comprising an exclusive collection of golf mansions, villas, and townhouses, the development saw 1,700 of its residences sold after few days of laun
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