AMRA Profiler 4 Gains EU MDR Certification, Expanding Global Impact in Body Composition Analysis

AMRA Medical, a pioneer in MRI-based body composition analysis, has achieved a significant milestone with the European Union's Medical Device Regulation (MDR) certification for its AMRA® Profiler 4. This approval is a testament to the device’s safety and effectiveness, meeting the stringent requirements set by the 2017/745 (EU) MDR for medical devices in Europe.

The AMRA® Profiler 4 had already earned FDA 510(k) clearance in the United States, and now, with the CE mark, it’s clear that AMRA is setting a high standard across both the EU and U.S. markets. This certification underscores AMRA's dedication to scientific rigor and innovation as the company pushes forward in making its MRI-based technologies a staple in clinical settings.

For clinicians, the AMRA® Profiler 4 offers a detailed look into body composition, providing essential biomarkers for fat distribution and muscle composition, including liver fat. This kind of precise data is invaluable for diagnosing and managing various conditions, offering insights that are tailored to each patient’s unique profile. The technology, which has already made significant contributions to metabolic disease research through AMRA’s Researcher service, is now even closer to being a standard tool in patient care.

Currently, the AMRA® Profiler 4 is available in the UK, US, and Canada, with plans to introduce it to the EU market soon. This expansion is a crucial step in making advanced body composition analysis more accessible to patients and healthcare providers across the globe.