FDA clears Naviscan PET scanner

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 writers
September 30, 2003

Related Reading

Positron emission mammography shows promise for breast imaging, October 28, 2002

Start-up enters breast imaging arena with scintimammography, PET offerings, March 14, 2001

PEM gets FDA nod for breast imaging device, February 14, 2001

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