Naviscan Receives 510(k) Clearance for Stereo Navigator(TM) - the First Commercially Available Breast PET-Guided Biopsy Feature

SAN DIEGO, Nov. 19 /PRNewswire/ -- Naviscan, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its biopsy-guidance feature designed exclusively for use with its high-resolution organ-specific PET scanner. The scanner's breast application is Positron Emission Mammography (PEM).

Stereo Navigator(TM), the PEM-guided biopsy accessory, is indicated for the localization of lesions in female breasts, as identified on a PET image. This guidance system will now enable physicians to guide compatible interventional devices towards abnormalities visible on PET.

This Stereo Navigator biopsy feature represents the cutting edge of targeted molecular imaging in the breast. The accessory uses a stereotactic frame fixed between the scanner's paddles to guide the insertion of a compatible interventional device into the breast. Accurate targeting is possible due to the high-resolution 3-D tomographic images acquired.

source: PR Newswire