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
Robbyant Releases LingBot-Touch to Bring General-Purpose Touch Perception to Robots10.11.2026 11:23:00 EET | Press release
Robbyant, an embodied AI company within Ant Group, today announced the open-source release of LingBot-Touch, a tactile foundation model that gives robots a critical missing sense by enabling robust touch perception. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109284905/en/ LingBot-Touch encodes magnetic tactile, visual tactile, and piezoresistive signals into unified tactile tokens for use by different action models. Pre-trained on nearly 5,000 hours of real-world tactile data, the model covers three mainstream sensing modalities—magnetic tactile, visual tactile, and piezoresistive sensing—and translates their diverse signals into a unified tactile representation. This allows different dexterous hands and action models to share and reuse tactile understanding, enabling robots to not only “see clearer” and “think deeper,” but also “feel sharper” during fine manipulation tasks, such as turning pages, unscrewing bottle ca
Heitman Partners with Talliosake to Establish Nordic Drive-Up Self-Storage Platform Talli10.11.2026 11:00:00 EET | Press release
Heitman LLC (“Heitman”), a global real estate investment management firm, today announced the launch of Talli, a new Nordic drive-up self-storage platform established through the acquisition of the majority of Talliosake Oy’s (“Talliosake”) rental operating business. Talliosake will remain a minority investor in Talli. Completed on behalf of Heitman’s European value strategy, the transaction establishes a platform for expansion across Finland and Sweden and builds on Heitman’s Nordic self-storage presence following its acquisition of the Servistore platform in Sweden in 2024. The Talli platform brings together the experienced management team that has driven Talliosake’s growth with Heitman’s global investment and operational capabilities. Since 2010, Talliosake has delivered more than 6,400 drive-up self-storage units across 230 properties in Finland and Sweden, building deep expertise in land acquisition, planning, development, leasing, and asset management. Together, Heitman and Tall
Quectel Launches EG216Q-GL and BG950Q-GL to Give IoT Device Makers a More Cost-efficient, Lower-power Upgrade Path10.11.2026 11:00:00 EET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announced the EG216Q-GL and BG950Q-GL, two next-generation global cellular IoT modules based on Qualcomm technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110650568/en/ Quectel launches EG216Q-GL and BG950Q-GL to give IoT device makers a more cost-efficient, lower-power upgrade path Built in Quectel’s widely adopted EG2 and BG95 form factors, the modules give device makers a direct route from established legacy platforms to a more cost- and power-optimized generation. Customers can reuse the board designs and development work they already have. The EG216Q-GL is an LTE Cat 1bis module for customers whose designs use Quectel’s EG2-footprint modules. These include the EC2x series, EC200A series, EG25-G, EG25-GL, EG21-G and EG21-GL, as well as the UC200A-GL. Because it shares their form factor, manufacturers can upgrade while keeping their
Wise Selects Navan to Modernize Global Travel Program10.11.2026 11:00:00 EET | Press release
Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced that Wise (Nasdaq:WSE, LSE:WISE), the global financial technology company building the best way to move and manage the world's money, has selected Navan to manage its business travel program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109603155/en/ Global financial technology company plans to improve traveler choice, cost control and visibility “Our teams travel across the world to work together and support our customers, so it's important that booking and managing travel is straightforward,” said Hanro Hennig, VP Global Real Estate, Workplace and Risk at Wise. “We're working with Navan to make that experience simpler, while giving us better visibility and control over travel costs.” Key anticipated benefits of the partnership include: Better choice: A wider range of airfares means that employees are offered a broader, be
OBI Group Will Adopt Blue Yonder Solutions to Unify Demand Planning and Replenishment Across 660+ European Stores10.11.2026 10:00:00 EET | Press release
OBI Group, a leading European Home and Garden retailer, has begun adopting Blue Yonder Demand Planning and end-to-end replenishment capabilities across its stores and distribution centers, with plans to ultimately deploy them to more than 660 stores across all of its markets. The deployment replaces multiple systems with a single, scalable platform. It also gives OBI AI-enabled forecasting and automated replenishment from distribution centers to store shelves, improving product availability for millions of customers across Europe. OBI selected Blue Yonder to consolidate fragmented planning systems into one integrated platform. That helps improve forecast accuracy across assortment types and planning timeframes while standardizing forecasting and replenishment processes across its network. Blue Yonder’s machine-learning capabilities and the prospect of future collaboration on a broader supply-chain transformation were key factors in OBI’s decision. Blue Yonder Professional Services led
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