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Emerging MRI-Based Technology for Assessing Muscle and Fat Gets FDA 510(k) Clearance


Utilizing biomarkers from magnetic resonance imaging (MRI) exams, AMRA Medical’s BCP Scan reportedly provides precise measurements of muscle and fat.

The Food and Drug Administration (FDA) has granted 510(k) clearance to the BCP (Body Composition Profile) Scan, a technology that enables clinicians to obtain accurate muscle and fat measurements from magnetic resonance imaging (MRI), according to AMRA Medical.

In contrast to obtaining a body mass index (BMI) or waist circumference number, AMRA Medical said its BCP Scan offers specific measurements of muscle, fat, and liver fat volumes. The company noted these measurements may help clinicians educate patients on associated health risks and initiate conversations about lifestyle changes to mitigate these risks.

For example, the BCP Scan can reportedly identify people with high visceral fat and low liver fat, a combination associated with a high heart disease risk, according to AMRA Medical. The company also suggested that the BCP Scan can help monitor weight loss efforts for obese people by determining whether they are losing visceral fat or if they are only losing subcutaneous fat.

AMRA Medical says its protocol for the BCP Scan only adds a couple of minutes to a prescribed MRI exam and generates a report that compares the patient’s body composition measurements to normative values from the company’s reference database as well as others of the same sex and body habitus.

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