AMRA
Profiler Cleared by FDA for
Body Composition Analysis from MRI Scans
AMRA Medical, a company based in*Link"oping, Sweden, won FDA clearance to introduce its
AMRA Profiler technology for fat and muscle
Composition analysis. The product relies on a six minute MRI scan, performed using a compatible scanner, with the imaging data being sent to AMRA’s servers. AMRA, in turn, delivers individualized reports that can be read by physicians and shared with patients.
The
AMRA Profiler is the first product able to convert a short MRI into a high quality 3D fat and muscle map, and provide the metabolic status, of the patient’s body. Specifically, the technology gives visual and values-based information on the visceral adipose tissue volume, subcutaneous adipose tissue volume, liver fat fraction, and thigh muscle volume.
The
AMRA Profiler does require a compatible MRI scanner, and the company works with providers to make sure the offering is installed so that there’s very little interaction that is required to receive
Body Composition Analysis reports for every patient getting the appropriate scan.
“We are delighted with the FDA’s decision. The challenges facing healthcare systems across the world are well-documented. Cost constraints, together with societal issues such as obesity and an aging population, are putting hospitals and private clinics under increasing pressure,” in a published statement said Eric Converse, CEO of
AMRA Medical. “AMRA®
Profiler helps address these challenges by providing physicians with the most detailed
Body Composition assessment and imaging available, cost-effectively and with minimal intrusion to the patient. Ultimately this enables clinicians to make more informed treatment decisions about the whole body. This clearance is the next step in our journey of translating the benefits of
AMRA into clinical practice and in ultimately contributing to the real world data and real world evidence that are playing an increasing role in health care decisions today.”
Link:
AMRA Medical homepage…
Via:
AMRA…
