AMRA Medical's MRI-Based Muscle Assessor Gains 510(k) Clearance

Sweden-based AMRA Medical’s MAsS Scan muscle assessment technology has received the FDA’s 510(k) clearance.

The MAsS Scan, which is offered as a medical device service, uses muscle and fat biomarkers from magnetic resonance imaging (MRI) scans to provide reports to clinicians for use in patient care.

The reports include a muscle assessment score, body composition measurements with insights based on AMRA's reference database, and anatomic and color-coded segmented images.

The scan report “creates a common language among clinicians with the muscle assessment score, and adds only minutes to an already prescribed MRI," the company said.