FDA clears Siemens PET/MR
"The Siemens PET/MRI system allows two tests to run simultaneously without having to move the patient to a different scanning system," stated Alberto Gutierrez, PhD, 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."
Biograph mMR comprises a 3T MR scanner and a PET detection system. While MR provides morphological and functional details in human tissue, PET investigates the human body at the level of cellular activity and metabolism.
With its simultaneous data acquisition, the system may help identify neurological, oncological and cardiac conditions of disease and support therapy planning, said Erlangen, Germany-based Siemens. The Biograph mMR also will support development of new biomarkers or therapeutic approaches.
"Combining MRI technology with PET in a single integrated system adds the advantages of the extremely broad spectrum of diagnostic MRI procedures to the arsenal of available PET procedures," said Alexander Drzezga, MD, of the department of nuclear medicine at the TU Muenchen in Munich who presented a study comparing the clinical performance of PET/CT and whole-body PET/MR at the annual meeting of SNM earlier this month.
"This could potentially result in the development of new imaging agents that bring together specific diagnostic strengths of PET and MRI. It offers exciting scientific options to image physiologic and pathophysiologic processes at the same time and to improve our understanding of both. This and further studies could potentially open a whole new hybrid imaging discipline within the field of nuclear medicine," Drzezga noted.
The FDA cleared the Siemens system based on bench tests that compared the device with a predicate PET/CT device. The Biograph mMR system is indicated for patients who need diagnostic PET or MRI imaging.
Earlier this month, Siemens Healthcare received the CE mark for Biograph mMR.