Swedish image analysis software developer AMRA Medical has secured a Medical Device Regulation (MDR) certificate in Europe for its Profiler 4 MRI-based body composition analysis software.
The European Union (EU) MDR certification follows the product's 510(k) clearance from the U.S. Food and Drug Administration and Canadian clearance, AMRA noted.
AMRA's automated body composition analysis derived from whole-body MRI scans is designed to provide clinicians with fat distribution (e.g. liver fat) and muscle composition biomarkers that comprise a profile to assist clinicians in diagnosis, AMRA said. The biomarkers underlying the technology may be useful in metabolic disease research, according to the vendor.
Profiler 4 is currently available in the U.K., U.S., and Canada. AMRA said it now plans to roll out the software in the EU "in the future."
