Siemens Gets FDA Nod For First Hybrid PET/MRI Scanner

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imageMarking the debut of the first equipment to enable simultaneous whole-body acquisition of data from magnnetic resonance (MR) and positron emission tomography (PET), Siemens Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Biograph mMR hybrid PET/MRI scanner.

The 3T hybrid system enables users to simultaneously generate the location, function, and metabolic activity of organs in a single image. It is said to allow a combined approach to imaging anatomical, functional and biochemical characteristics of disease. Potential clinical applications for molecular MR, such as that offered by Biograph mMR, include the early identification and staging of malignancies, therapy planning, and treatment.

Indeed, combined PET/MRI in general has the potential to broaden horizons in the emerging field of molecular imaging because it permits complementary anatomic and biologic information to obtained and synergisms of both modalities can be expected., note the authors of “PET/MRI: Paving the Way for the Next Generation of Clinical Multimodality Imaging Applications”, published in the March, 2010 issue of The Journal of Nuclear Medicine.

In their article, authors Bernd J. Pichler and Armin Kolb, of the Laboratory For Pre-Clinical Imaging Technology of the Werner Siemens Foundation, Department of Radiology, University of Tubingen, Tubingen, Germany; and Thomas Nagele and Heinz-Peter Schlemmer, of Tubingen University’s Department of Diagnostic and Interventional Neuroradiology and Department of Diagnostic and Interventional Radiology, respectively, note that criticism of the hybrid modality is nevertheless justified.

“The novel imaging technology may not enter clinical routine before its impact on diagnostic accuracy has been proven, and the effect on therapy management and cost-efficiency has been considered and validated, “ they write.

For example, they say, it must be determined which unmet clinical needs can be addressed by PET/MRI, why higher diagnostic accuracy is anticipated compared with sequentially performed PET and MRI, and what the added value could be with respect to the established PET/CT technology.

The high cost of integrated PET/MRI systems, they assert, must be also be considered in order to establish what level of hardware integration is really mandatory to meet clinical requirements.

“Capabilities and limitations of PET/MRI must be balanced and compared with PET/CT by considering technologic, scientific, medical, and economic aspects,” the researchers elaborate. “It should not be forgotten that CT is a robust, widely distributed, and relatively inexpensive imaging modality that has evolved into a standard diagnostic tool in clinical practice. In combined PET/CT, cross-talk effects are virtually nonexistent and CT data can be used directly for the PET attenuation correction and image reconstruction.”

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