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Siemens receives 510k clearance of Biograph mMR

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The FDA granted Siemens Healthcare 510k clearance for the Biograph mMR, a system which enables simultaneous whole body acquisition of data from magnetic resonance and positron emission tomography (PET).

“Integrating these two powerful modalities into one simultaneous whole body system represents a breakthrough innovation. More powerful diagnostic tools can bring greater efficiency to health care and can help to improve human health,” Gregory Sorensen, MD, chief executive officer of Siemens Healthcare USA and Canada, stated in a company release.

The Biograph mMR enables users to generate the location, function and metabolic activity of organs in a single image at the same time. The system integrates diagnostic-grade MR and PET into a single-gantry whole body scanner with 3T MR technology and Avalanche photodiode solid-state PET detector technology. Accordng to the release, patients can be scanned in as few as 30 minutes for a combined whole body exam. Additionally, Biograph mMR has a footprint comparable to a standard, high-field MR scanner and can be sited in a typical MR room.