AMRA Medical's MRI-Based Muscle Assessment Technology Receives FDA 510(k) Clearance
LINKÖPING, Sweden, Dec. 7, 2021 /PRNewswire/ -- 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(k) 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 (Muscle Assessment Score) uses muscle and fat biomarkers from magnetic resonance imaging (MRI) 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.
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SOURCE AMRA Medical
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