AMRA Medical's MRI-Based Muscle Assessment Technology Receives FDA 510 Clearance

AMRA医疗公司基于MRI的肌肉评估技术获得FDA 510许可

2021-12-07 23:00:06 BioSpace

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 AMRA Medical, a ground-breaking digital health company and global leader in body composition analysis, announced today that the AMRA® MAsS Scan has received a 510 clearance from the FDA. This expands AMRA's reach with the MAsS Scan as it was recently permitted for use in Canada. The MAsS Scan uses muscle and fat biomarkers from magnetic resonance imaging scans to provide objective and actionable data to clinicians in the US. The AMRA® MAsS Scan is offered as a medical device service, utilizing AMRA's rapid neck-to-knee MRI protocol, to produce an easy-to-understand and actionable patient-specific report. The report contains the muscle assessment score (MAsS), precise body composition measurements with contextual insights based on AMRA's reference database, and anatomic and color-coded segmented images. Together, the images and the precise biomarkers derived from the images yield information for clinicians to support patient care. Eric Converse, CEO at AMRA, commented: "We are very excited to expand this technology to the US. The AMRA® MAsS Scan will greatly benefit patients by allowing clinicians to objectively and accurately assess muscle quality and take action to ultimately improve patient outcomes." Converse continued: "The beauty of the report is that it is easy-to-understand, it creates a common language among clinicians with the muscle assessment score, and adds only minutes to an already prescribed MRI." Learn more about the AMRA® MAsS Scan on AMRA's website. About AMRA Medical AMRA is a digital health company at the forefront of medical imaging and precision medicine. The company has developed a new global standard in body composition analysis, the ability to automatically produce multiple fat and muscle biomarkers with unrivaled precision and accuracy, as well as contextual disease insights – all from a single, rapid, whole-body MRI scan. multimedia:https://www.prnewswire.com/news-releases/amra-medicals-mri-based-muscle-assessment-technology-receives-fda-510k-clearance-301438683.html
AMRA医疗,一个开创性的数字健康公司和身体成分分析的全球领导者,今天宣布,AMRA®大规模扫描已经收到了美国食品和药物管理局的510许可。这扩大了AMRA的范围与质量扫描,因为它最近被允许在加拿大使用。肿块扫描使用来自磁共振成像扫描的肌肉和脂肪生物标志物,为美国的临床医生提供客观和可操作的数据。 AMRA®MAsS Scan是作为一种医疗设备服务提供的,利用AMRA的快速颈部至膝盖MRI协议,生成一份易于理解和可操作的患者特定报告。该报告包含肌肉评估评分(质量),精确的身体成分测量与背景洞察的基础上AMRA的参考数据库,解剖学和颜色编码分割图像。图像和从图像中提取的精确生物标志物一起为临床医生提供支持病人护理的信息。 AMRA首席执行官Eric Converse评论道:“我们非常兴奋将这项技术扩展到美国。AMRA®大规模扫描将使患者受益匪浅,因为它允许临床医生客观准确地评估肌肉质量,并采取行动最终改善患者结局。”匡威继续说道:“这份报告的美妙之处在于它容易理解,它在临床医生之间用肌肉评估评分创建了一种共同语言,并且只为已经开出的核磁共振增加了几分钟。” 在AMRA的网站上了解更多关于AMRA®大规模扫描的信息。 关于AMRA医疗 AMRA是一家位于医学影像和精准医学前沿的数字健康公司。该公司在身体成分分析方面开发了一个新的全球标准,能够以无与伦比的精确度和准确性自动产生多个脂肪和肌肉生物标志物,以及上下文疾病洞察--所有这些都来自单一、快速、全身MRI扫描。 多媒体:https://www.prnewswire.com/news-releases/amra-medicals-mri-based-muscle-assisment-technology-receives-fda-510k-clearance-301438683.html

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