GE Healthcare has been issued a 510(k) clearance notification by the U.S. Food and Drug Administration for its PET Volume Computed Assisted Reading (VCAR) software.
VCAR first arrived on the scene in 2005 as an application designed to detect pulmonary nodules on multislice CT examinations. The VCAR CT software combines automatic nodule detection with volumetric assessment at initial and follow-up studies, according to GE.
The Chalfont St. Giles, U.K.-based vendor stated in its 510(k) application for the software package that it automatically highlights and bookmarks PET-defined regions of interest based on user-defined threshold settings. It can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multiple exam comparison.
The software is designed to measure standardized uptake values (SUV) and volume for any PET-defined metabolic activity. It automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow, GE said.
The company stated in its application that the PET VCAR software does not provide or claim any automatic detection or diagnosis of abnormal anatomy, structure, or function.
GE will showcase the new application at the 2007 SNM conference in Washington, DC, this June.
By AuntMinnie.com staff writers
April 20, 2007
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