Siemens syngo.PET Amyloid Plaque Software Receives FDA Clearance

August 21, 2012 — Siemens Healthcare announced that its syngo.PET Amyloid Plaque proprietary software has received clearance from the U.S. Food and Drug Administration (FDA) and is now available.

Joining the new Biograph mCT positron emission tomography/computed tomography (PET/CT) scanner and PETNET Solutions’ PET radiopharmaceutical production expertise, syngo.PET Amyloid Plaque software is the third element in Siemens’ comprehensive imaging solution for the visualization and quantification of amyloid plaques – one of the necessary pathological features of Alzheimer’s disease – in the living brain.

“Our new syngo.PET software, combined with Siemens’ Biograph mCT PET/CT scanner and expertise in the production of PET radiopharmaceuticals, will provide U.S. physicians with a valuable tool for the evaluation of Alzheimer’s disease and other neurologic conditions,” said Britta Fuenfstueck, CEO of molecular imaging at Siemens Healthcare.

syngo.PET Amyloid Plaque software is designed to assist physicians with assessment of beta amyloid uptake ratios in the PET scans of patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. The software registers a patient’s PET amyloid images against a reference model of a PET amyloid brain to better enable the physician to target regions of interest. Siemens’ proprietary affine registration algorithm has been demonstrated in research to have a correlation coefficient of 0.98 to the Fleisher method, a reference model that identifies six optimal zones to evaluate pathological levels of amyloid plaque burden. syngo.PET Amyloid Plaque software enables physicians to quantify uptake ratios (SUVr), which can be compared to Fleisher thresholds. Quantification of amyloid-PET images with SUVr could provide information in patients with possible mild cognitive impairment that is useful in supporting visual reads of amyloid-PET images.

syngo.PET Amyloid Plaque software is cleared for use with PET and PET/CT equipment.

For more information: www.siemens.com/alzheimers