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Naviscan Receives 510(k) Clearance for Stereo Navigator(TM) - the First Commercially Available Breast PET-Guided Biopsy Feature
Date:11/19/2008

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.

"The strength of our high-resolution PET scanner has always been the ability to resolve suspicious lesions down to 2 mm," said Paul Mirabella, Chairman & CEO. "Now we can also offer biopsy guidance, providing physicians with the all important pathological confirmation to determine the optimal course of treatment."

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. Localization of the abnormality is verified using a PET-visible line source that is inserted into the needle track allowing the user to confirm trajectory and position. The accessory is compatible with the following breast biopsy systems: Mammotome(R) from Ethicon Endo-Surgery, Inc., ATEC(R) from Hologic, Inc., and EnCor(R) from SenoRx Corporation.

Stereo Navigator represents the latest innovation from Naviscan which will be showcased at the Radiological Society of North America's 94th Scientific Assembly and Annual Meeting in Chicago, November 30-December 5, 2008.

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