AMRA Medical Gains FDA Clearance, Canadian Approval for Muscle Assessment Tech

AMRA Medical has received 510(k) clearance from the FDA and a Canadian medical device establishment license for its Body Composition Profile (BCP) Scan.

The BCP Scan analyzes muscle and fat biomarkers from magnetic resonance imaging (MRI) scans to provide data to clinicians, according to the Sweden-based company.

The image analysis provides patient-specific measurements, such as muscle, fat and liver fat volumes, with a comparison to others of the same sex and body type, based on AMRA's reference database.

The report has a variety of uses. For example, if it detects a high level of visceral fat — which is associated with a higher risk of type 2 diabetes and heart disease — the physician may advise the patient to make lifestyle changes aimed at reducing fat.