PET/MRI Combo Wins FDA Approval

The U.S. Food and Drug Administration on Friday approved the Siemens Biograph mMR system for use in the United States. It’s the first device approved to simultaneously perform a positron emission tomography (PET) and magnetic resonance imaging (MRI) scan in the US.

PET/computer tomography (CT) scanners are well known. But the new machine has several advantages over PET/CT, the FDA says, including “simultaneous imaging, reduced radiation dose, and increased soft tissue contrast.

Image courtesy of Siemens

"The Siemens PET/MRI system allows two tests to run simultaneously without having to move the patient to a different scanning system," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health. "Minimizing changes in a patient's position between tests allows physicians to compare images more easily and helps them get the most accurate information possible."

The new machine was approved last week for sale in Europe.
 

As with PET/CT machines, the Biograph mMR uses PET to observe organ and tissue function, but the new machine boasts the superior resolution of MRI, which could provide physicians with more information about a patient’s condition, the FDA said. The agency added that the MRI’s lack of ionizing radiation means the Biograph system exposes patients to a “significantly lower radiation dose” than a PET/CT system. The decreased radiation dose is especially significant for sensitive populations such as children or patients receiving multiple scans, the agency said.
 

The FDA cleared the Siemens system based on bench tests comparing the device with a PET/CT machine. The Biograph mMR system is indicated for anyone who needs diagnostic PET or MRI imaging, though patients with pacemakers, defibrillators or other implanted electronic devices should avoid the Biograph mMR unless those devices are specifically indicated for use in the highly magnetic environment.

The Biograph mMR is made by Siemens Medical Solutions of Malvern, Pa.