AMRA receives FDA clearance for MRI body composition measurement software

AMRA Medical, a Swedish company specializing in body composition analysis software, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AMRA® Profiler software. AMRAProfiler precisely measures fat volumes, fat fractions, and lean tissue volumes, enabling the generation, display and review of magnetic resonance imaging (MRI)-based body composition measurements. It is intended as a decision support tool for use in clinical practice.

The software transform MR-images from a 6-minute whole-body MRI scan into 3D-volumetric fat and muscle measurements, enabling outstanding accuracy and precision when assessing volume and distribution of fat and muscles, as well as metabolic status, according to the Linköping-headquartered company. AMRAProfiler provides body composition measurements, that include visceral adipose tissue volume, subcutaneous adipose tissue volume, liver fat fraction, and thigh muscle volume, alongside associated medical images.

The AMRAProfiler is also CE marked in Europe and available for clinical use in Sweden, UK and Germany.