AMRA Receives U.S. FDA Clearance for AMRA® Profiler, a Magnetic Resonance Diagnostic Software Application Enabling Non-Invasive Evaluation of Body Composition
AMRA Medical (“AMRA”), the international leader in body composition analysis, announced today that it has received FDA clearance for AMRA® Profiler, now available for use in a clinical setting in the US. AMRA® Profiler is indicated for use as a magnetic resonance (MR) diagnostic device for non-invasive fat and muscle evaluation that enables the generation, display and review of MR-based body composition measurements.
AMRA is the first in the world to transform MR-images from a 6-minute whole-body MRI scan into 3D-volumetric fat and muscle measurements, enabling outstanding accuracy and precision when assessing volume and distribution of fat and muscles, as well as metabolic status.
“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, ” stated Eric Converse, CEO of AMRA.
“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 .”
AMRA® Profiler provides a number of body composition measurements, such as visceral adipose tissue volume, subcutaneous adipose tissue volume, liver fat fraction, and thigh muscle volume, alongside associated medical images. These body composition measurements and images, when interpreted by a trained physician, may yield information that assists in diagnosis.
AMRA’s mission is to establish a new global standard in body composition analysis and confront global health challenges by enhancing the evidence base needed to predict and prevent disease.
Notes to editor:
AMRA is a ground-breaking, international digital health company at the forefront of medical imaging and precision medicine. The company has developed a new global standard in body composition assessment, delivering multiple fat and muscle biomarkers with unrivalled precision alongside contextual disease insights – all from a 6-minute whole-body MRI scan. AMRA was founded in 2010 as a spin-off of Linköping University, Sweden, with the aim to support transformative care and vital decision-making, from clinical research to clinical care.
AMRA® Profiler precisely measures fat volumes, fat fractions, and lean tissue volumes - precise body composition measurement available as a decision support tool for use in clinical practice. AMRA® Profiler is also CE marked in Europe and available for clinical use in Sweden, UK and Germany.
For more information, visit www.amramedical.com
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