AMRA Medical, a ground-breaking digital health company and global leader in body composition analysis offering medical device and medical research services, announced today that AMRA has received 510(k) clearance from the FDA and MDEL (Medical Device Establishment Licence) licensing.
AMRA Medical is now permitted to distribute AMRA® BCP Scan (Body Composition Profile) in the US and Canada. The BCP Scan uses muscle and fat biomarkers from magnetic resonance imaging (MRI) scans to provide objective and actionable data to clinicians.
The AMRA® BCP Scan is offered as a medical device service to promote health and wellness. The technology utilizes AMRA’s rapid neck-to-knee MRI protocol, to produce an easy-to-understand and actionable patient-specific report. The report contains patient-specific body composition measurements, such as muscle, fat, and liver fat volumes, with a comparison to normative values based on AMRA’s reference database. The report goes further to compare the patient with others of the same sex and body habitus, making the results even more personalized. The body composition measurements derived from the MR images provide information that may promote healthy lifestyle choices. For instance, if the BCP Scan detects a high level of visceral fat—which is associated with a higher risk of type 2 diabetes and heart disease—a physician evaluating the results may decide to encourage a lifestyle change of his or her patient that has been shown to reduce visceral fat.
Eric Converse, CEO at AMRA, commented: “We are thrilled to expand this technology to the US and Canada. The AMRA® BCP Scan brings health assessment into a new era. Rather than relying on BMI or waist circumference, we have precise fat and muscle measurements so a physician can really see what is going on inside the body.” Converse continued: “Our protocol only adds minutes to an already prescribed MRI, and because we deliver the results through a simple report, clinicians and patients can easily understand the information and potentially use that information to make healthy lifestyle choices.”