Naviscan, the leader in organ-specific molecular imaging, announced today that it obtained CE Mark approval for both its high-resolution PET scanner and PETguided biopsy accessory. The breast application of the scanner is Positron Emission Mammography (PEM).
Naviscan has expanded its distribution into 13 European countries and has already received its first two orders in Germany and Switzerland.
Naviscan manufactures the only commercially-available, high-resolution PET scanner with PET-guided biopsy system. The scanner uses PET technology to produce tomographic images that allow physicians to visualize breast tumors with an unprecedented resolution of 1.6 mm, about the width of a grain of rice. In recently published data, PEM has been found to be significantly more precise than existing technologies at identifying benign and cancerous lesions, in what scientists call “specificity,” therefore reducing the number of unnecessary biopsies. This finding is a welcomed outcome for women and physicians looking for ways to reduce the patient trauma and cost associated with unnecessary procedures.
“CE Mark approval for Naviscan’s technology is a significant accomplishment and we are thrilled that women in Europe can now benefit from our 3-D, high-resolution, molecular breast imaging (MBI) system,” stated Paul Mirabella, Chairman and CEO of Naviscan. “We look forward to continuing to help detect and treat breast cancer on an even greater global scale.”
Naviscan, founded in 1995, develops and markets compact, high-resolution PET scanners intended to provide organ-specific molecular imaging and guide radiological and surgical procedures. The Naviscan PET scanner is currently installed and available in breast and imaging centers throughout the U.S. and other parts of the world. The Company is headquartered in San Diego, California and is the first to obtain both FDA-clearance and CE Mark approval for a high-resolution PET scanner designed to image small body parts and for breast biopsy image guidance. For more information, call 1.858.587.3641 or visit www.naviscan.com