LINKÖPING, Sweden--(BUSINESS WIRE)--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.

瑞典林克平--（商业新闻短讯）--AMRA Medical是基于MRI的身体成分分析和生物标志物开发的领先力量，很高兴宣布其尖端AMRA®Profiler 4身体成分分析设备的欧盟医疗器械法规（MDR）证书。

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.

。在将医疗器械推向欧盟市场之前，医疗器械制造商必须确保符合MDR。

These requirements ensure that a medical device placed on the European market is both safe and effective for use by patients and providers..

这些要求确保投放欧洲市场的医疗器械对于患者和提供者来说既安全又有效。。

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.

该证书是美国食品和药物管理局（FDA）对AMRA®Profiler 4 510（k）许可的继承，符合欧盟和美国市场的高标准，推动AMRA尖端身体成分分析方法在临床上的应用。既然AMRA®Profiler 4带有CE标志，那么该设备与欧洲MDR一般安全和性能要求的一致性就显而易见了。

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在产品开发中始终表现出强大的科学方法和成熟度，因为他们继续在临床上转化其令人兴奋的基于MRI的技术方面采取关键步骤。。

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.

AMRA®Profiler 4为临床医生提供脂肪分布，例如肝脏脂肪和肌肉成分生物标志物，这些生物标志物包含详细的身体成分特征，以帮助诊断。AMRA®Profiler 4可在诊所实施，可提供与标准数据相关的快速而精确的身体成分测量，并可在个体患者层面上提供情境化的见解，具有很高的准确性。

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..

该技术的基础AMRA生物标志物已被证明可用于使用AMRA®研究人员服务的代谢疾病研究工作，AMRA®Profiler 4最近的MDR认证使这些强大而独特的生物标志物更接近世界各地的患者。。

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..

目前，AMRA®Profiler 4通过AMRA在英国、美国和加拿大提供的服务完全可用，并计划在此MDR证书里程碑之后在欧盟推出该产品。如果您或您的组织位于当前已清算的市场，并且希望了解有关将AMRA®Profiler 4带到您的诊所的更多信息，请联系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..

您可以通过访问我们的网站或与我们的知识渊博的科学家联系，了解AMRA如何使用基于MRI的脂肪分布和肌肉成分评估来推进研究和临床护理info@amramedical.com了解更多有关AMRA可以为您的试验或患者做什么的信息。。

About AMRA Medical

关于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 Medical是一家健康信息学和精准医学公司，开创了人体成分分析的先河，为推进临床研究和患者护理计划提供了前沿解决方案。AMRA的金标准技术提供多种脂肪和肌肉生物标志物，这些标志物仅来自快速的全身MRI扫描。

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..

AMRA致力于通过其创新平台提供服务，推动变革性护理，简化研究和临床护理环境中的重要决策。。

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.

了解有关AMRA Medical基于MRI的解决方案的更多信息，请访问https://amramedical.com/solutions，或与我们的专家团队联系，在info@amramedical.com.

Follow AMRA on LinkedIn for the latest updates in fat distribution and muscle composition assessments in disease research and precision medicine.

关注LinkedIn上的AMRA，了解疾病研究和精准医学中脂肪分布和肌肉成分评估的最新更新。