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 unrivaled precision alongside contextual disease insights – all from a 6-minute whole-body MRI scan. AMRA aims to support transformative care and vital decision-making, from clinical research to clinical care.
The AMRA® Profiler
AMRA Medical’s product, AMRA® Profiler, received FDA clearance with the support of Arazy Group. AMRA® Profiler measures fat and muscle volumes from 3D images obtained through an MRI scan. These images and the physical parameters derived from the analysis, when interpreted by a trained clinician, yield information that may assist in the diagnosis and monitoring of a multitude of diseases. It supports the analysis of multiple biomarkers, providing a time-efficient, cost-effective and innovative approach to analyzing complex pathological processes.
Janne West, VP Quality Assurance & Regulatory Affairs, has experience using the LICENSALE platform for the AMRA® Profiler’s FDA clearance. AMRA’s regulatory affairs team is very impressed with the workflow and professionalism the Arazy Group offered. AMRA believes that the Licensale platform can be a strong asset to medical and IVD device manufacturers when managing regulatory compliances across the globe.
AMRA Medical was founded in 2010 by Magnus Borga and Olof Dahlqvist. Headquartered in Sweden, AMRA was founded as a spin-off of Center for Medical Image Science and Visualization (CMIV), the Department of Biomedical Engineering (IMT), and the Department of Medicine and Health (IMH) at Linköping University, Sweden.
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