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
Rubedo’s RLS-1496 Reduces Actinic Keratosis Pre-Cancerous Skin Lesions by 46% at Four Weeks with Minimal Irritation in Preliminary Results of Phase 1b/2a Study28.5.2026 15:30:00 EEST | Press release
Rubedo Life Sciences, Inc. (Rubedo), an AI-driven, clinical-stage biotech focused on selective cellular rejuvenation medicines targeting aging cells, today announced preliminary results from a Phase 1b/2a study of RLS-1496 in patients with actinic keratosis (AK), a common age-related condition resulting in precancerous skin lesions, that is most commonly seen after age 65.1 The open-label multi-center trial, conducted in the United States, assessed the safety, tolerability, and clinical effects of RLS-1496 1% cream in adult patients with AK on the forearms. RLS-1496 is the first selective glutathione peroxidase 4 (GPX4) modulator to be studied in human trials, and the first targeting cellular rejuvenation as a new therapeutic pathway in a novel category called Adaptive SenoTherapeutics. Interim data from the study were presented at the RBC Capital Markets Global Healthcare Conference in New York City on May 19, 2026. Preliminary RLS-1496 Actinic Keratosis Trial Results The Phase 1b/2a
ExaGrid Wins 5 Industry Awards at Network Computing Awards 202628.5.2026 15:00:00 EEST | Press release
ExaGrid®, the world’s largest independent backup storage vendor providing Tiered Backup Storage with the most Comprehensive Security and AI-Powered Retention Time-Lock for Ransomware Recovery, today announced that company was honored with five industry awards, including Air-gapped Ransomware Recovery Product of the Year, Bench Tested Product of the Year, Company of the Year, Data Protection Product of the Year, and the Storage Product of the Year during the Network Computing Awards ceremony, held in London on May 21, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260528849813/en/ The ExaGrid team headed to the stage five times throughout the Network Computing Awards ceremony in London to accept awards for ExaGrid Tiered Backup Storage. Photo courtesy of Network Computing Awards. The Network Computing Awards are determined by public vote. The 2026 awards mark the eighth consecutive year of wins for ExaGrid at the Networ
Ardoq Launches AI-First Enterprise Architecture Platform28.5.2026 15:00:00 EEST | Press release
Ardoq, named a 5x Leader in the Gartner® Magic Quadrant™ for Enterprise Architecture Tools, today launched its AI-first enterprise architecture (EA) platform. The release grounds every Ardoq AI output in customers' live architecture data and introduces a new generation of AI agents capable of automating an estimated 40% of routine EA work. Architects today are being asked to defend decisions that generic AI is generating in seconds. Application rationalization choices. ERP transformation roadmaps. AI governance reviews. The questions land on the architect's desk, but the analysis underneath increasingly comes from AI assistants that do not know the architecture. Generic agents reason on whatever document is in front of them, not on the live relationships between applications, dependencies, capabilities, and risks. Ask a generic LLM to trace a five-step dependency chain across the real estate, and accuracy collapses. The answer arrives with confidence. The architect inherits the consequ
European DataWarehouse Launches DealDox ® , a Next-Generation Virtual Data Room Built specifically for the Securitisation Market28.5.2026 15:00:00 EEST | Press release
European DataWarehouse (EDW) announced today the launch of DealDox®, a secure virtual data room uniquely tailored to the needs of the securitisation and structured finance market. Developed in response to long‑standing challenges around transaction data and document management, DealDox provides a single, secure environment where all parties throughout the deal lifecycle can collaborate efficiently while maintaining high standards of security, governance, and regulatory alignment. DealDox enables the centralised management of transaction data and documentation, offering robust security, granular access controls, and clear audit trails. The platform integrates seamlessly with EDW’s existing regulatory reporting ecosystem, supporting smoother workflows from deal preparation through to disclosure and compliance. “As a market infrastructure, our role is to reduce complexity and make processes simpler and more transparent for all participants,” said Dr. Christian Thun, CEO of European DataWa
SLB and Vår Energi Expand Digital Collaboration to Scale Well and Integrated Field Development Planning28.5.2026 14:47:00 EEST | Press release
Global energy technology company SLB (NYSE: SLB) today announced an expanded collaboration with Vår Energi to scale well planning and integrated field development planning across its Norwegian Continental Shelf operations. With collaborative well planning already reducing cycle times from months to days and integrated field development planning expected to support similar benefits, the expanded deployment is designed to support faster, more consistent decision-making as operators work to sustain production from mature offshore assets while managing increasing development complexity. As part of the expanded collaboration, Vår Energi is deploying the Delfi™ digital platform to connect exploration, subsurface evaluation, well planning, subsea design, field development planning, and production in a cloud-native environment. By enabling teams to work concurrently using shared data and standardized workflows, the approach reduces handoffs and rework and supports more consistent, timely decis
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