The Food and Drug Administration has cleared PEM Flex, a compact, high-resolution PET scanner developed by Naviscan PET Systems of Rockville, MD. Naviscan says the system’s image quality -- 1.5-mm intrinsic spatial resolution -- makes it ideal for imaging small body parts such as the breast, head, hand, or foot.
PEM Flex can operate either in a stand-alone configuration or with digital images from other modalities. Naviscan is recruiting sites for clinical trials to assess the product’s ability to guide breast surgery. A recently published pilot study suggested that by comparing tumor radiopharmaceutical uptake to fat uptake in the breast, PEM Flex achieved a sensitivity and specificity of 86% and 91%, respectively, for identifying breast cancer.
Naviscan was previously known as PEM Technologies.
By AuntMinnie.com staff writersSeptember 30, 2003
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