FDA clears Siemens neuro package

Siemens Healthcare has received FDA 510(k) marketing clearance for its syngo Neuro PBV IR software package.

Syngo Neuro PBV IR (Parenchymal Blood Volume Interventional Radiology) is intended to provide visual assistance to physicians in the diagnosis and treatment of vessel malformations (such as aneurysms, arteriovenous malformations and stenoses), explained the Erlangen, Germany-based Siemens. In neuroradiology, this feature assists physicians in the treatment of stroke patients by displaying a color-coded qualitative map of cerebral tissue directly in the angiography suite.

Syngo Neuro PBV IR further expands the Siemens imaging application portfolio for the Artis zee line of interventional x-ray systems for radiology and cardiology. The software package uses cone-beam CT technology (syngo DynaCT) to produce a qualitative colorized image similar to CT perfusion. It is designed for the visualization of contrast-enhanced blood distribution in the arterial and venous vessels in the head using color-coded relative values for diagnosis.

Parenchymal blood volume information is acquired with two C-arm rotations around the patient and a steady-state contrast injection. The system applies processing algorithms to generate a neurological PBV map. 

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