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
Cessna Citation Ascend Enters Into Service, Redefining Performance and Cabin Experience in the Midsize Business Jet Market31.12.2025 15:00:00 CET | Press release
The Cessna Citation Ascend achieved a major milestone as the first retail customer took delivery of the midsize business jet on Tuesday, December 30, marking the aircraft’s entry into service. Announced in 2023 the aircraft boasts an entirely new cockpit, improved performance and a luxurious flat floor cabin. The Citation Ascend received type certification from the Federal Aviation Administration (FAA) in November 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251231586042/en/ Cessna Citation Ascend enters into service, redefining performance and cabin experience in the midsize business jet market. (Photo credit: Textron Aviation) The Cessna Citation Ascend is designed and manufactured by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. “The first Citation Ascend delivery underscores Textron Aviation’s commitment to redefining the midsize segment with an aircraft that blends innovation, efficiency and unmatch
Aster Guardians Global Nursing Award 2026 Worth $250,000 Extends Deadline Till 11th January 202631.12.2025 14:08:00 CET | Press release
Due to an extraordinary global response of over 134,000 registrations from 214 countries, the submission deadline has been extended.Nurses worldwide can submit their nominations via www.asterguardians.com The Aster Guardians Global Nursing Award 2026, an initiative from Aster DM Healthcare – a leading integrated healthcare provider, has announced the extension of its deadline to January 11, 2026. The awards have already received over 134,000 registrations from 214 countries, highlighting its growing global reach and recognition among nurses worldwide. Nurses from around the world can submit their nominations through the dedicated platform at www.asterguardians.com. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251231986766/en/ Aster Guardians Global Nursing Award worth USD 250,000 (Photo: AETOSWire) This year, the prestigious award will be hosted in New Delhi, India, celebrating nursing excellence on a truly global stage. T
Tecnotree Included as a Representative Provider in Gartner® Innovation Insight: AI SOC Agents Accelerate CSP SecOps Transformation31.12.2025 11:59:00 CET | Press release
Tecnotree, a global digital platform and services provider for communications service providers (CSPs), today announced that it has been referenced as a Representative Provider alongside Google, Anthropic, Dropzone AI, DRUID, Palo Alto Networks, and Pegasystems in the Gartner® Innovation Insight: “AI SOC Agents Accelerate CSP SecOps Transformation,” published in December 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251231210303/en/ Tecnotree Included as a Representative Provider in Gartner® Innovation Insight: AI SOC Agents Accelerate CSP SecOps Transformation The Gartner Innovation Insight examines the emerging role of AI-driven Security Operations Centre (SOC) agents in CSP environments, outlining how these agents are used to automate and augment security operations across signalling, core networks, RAN, Open RAN, and roaming domains. The research discusses use cases such as alert triage, investigation support, thr
UAE’s Medcare Treats First International SMA Patient With Revolutionary Intrathecal Gene Therapy30.12.2025 15:15:00 CET | Press release
The newly licensed intrathecal gene therapy expands life-changing treatment options for children and adults affected by SMA Medcare Women & Children Hospital has successfully administered a pioneering intrathecal gene therapy for Spinal Muscular Atrophy (SMA) to Hulus, a three-year-old patient from Turkey. This milestone positions Medcare among the first private healthcare providers worldwide to offer this innovative treatment to an older international patient, overcoming previous age and weight limitations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251230695275/en/ World's first international patient, who received intrathecal gene therapy at Medcare Royal Hospital in Dubai, UAE, along with parents, and the hospital team. (Photo: AETOSWire) SMA is a rare neuromuscular disorder that progressively weakens muscles responsible for movement and breathing. This newly licensed one-time therapy addresses the root genetic cause
Amazfit Introduces Active Max: Bigger, Brighter, and Built for Maximum Performance30.12.2025 09:00:00 CET | Press release
The newest member of the Active family blends new design, expanded storage, and longer battery to help users train smarter and reach their goals with confidence. Amazfit, a leading global smart wearable brand by Zepp Health (NYSE: ZEPP), today announces the Amazfit Active Max, the newest member of the Amazfit Active family. Built for everyday athletes and anyone looking to elevate their wellness routine, Active Max blends a 1.5″ ultra-bright AMOLED display, up to 25 days of battery life, easy podcast listening and advanced training tools to support consistent training and clearer visibility across any activity. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251230279762/en/ Bigger Display. Max Clarity: A 1.5″ ultra-bright AMOLED display delivers exceptional clarity in any setting—whether in the gym, outdoors, or on the move. With up to 3,000 nits of peak brightness, the screen ensures real-time stats are always easy to read.
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