FDA clears Siemens' Biograph mMR

The FDA has granted Siemens Healthcare 510(k) clearance for the Biograph mMR, the first system to allow for whole-body data acquisition from magnetic resonance and positron emission tomography.

PET scans allow healthcare providers to see how the organs and tissues inside the body are functioning by injecting a radioactive chemical tracer into the patient's bloodstream. MRI uses magnetic fields and radiowaves to produce detailed images of organs, soft tissues, bone and other internal body structures.

The Biograph mMR system allows physicians to acquire images at a significantly lower radiation dose compared to a PET/CT system. Although the radiation dose from the PET exam remains unchanged, MRI does not use ionizing radiation, so the entire ionizing radiation dose from the CT scan is eliminated.

The FDA's Alberto Gutierrez said the system will allow the two test to run at the same time without having to move the patient to a different scanning system. "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," Gutierrez says in an agency statement.

According to the company, the integration of MR and PET technologies was nearly impossible previously. Conventional PET detectors, which use photomultiplier tubes, could not be used in the strong magnetic field generated by an MR system. Integration was further limited by the lack of space inside the MR device.

- see the FDA's release
- check out the release from Siemens