Technology | November 20, 2008

FDA Clears Naviscan Stereo Navigator for Breast PET-Guided Biopsy

Navi Stereo Navigator

November 20, 2008 - Naviscan Inc. said the FDA has granted 510(k) clearance for its biopsy-guidance feature designed exclusively for use with its high-resolution organ-specific PET scanner, Positron Emission Mammography (PEM).

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

Naviscan will showcase the Stereo Navigator at RSNA 2008 next week in Chicago.

This Stereo Navigator biopsy feature reportedly 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 3D 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 from Ethicon Endo-Surgery Inc., ATEC from Hologic Inc., and EnCor from SenoRx Corp.

Related Content

News | Breast Imaging | November 26, 2019
November 26, 2019 — Unifi Workspace, a new comprehensive breast diagnostic reading solution from Hologic, will launch
A patient prepares to have a tomosynthesis-guided prone breast biopsy using the Hologic Affirm prone biopsy system.

A patient prepares to have a tomosynthesis-guided prone breast biopsy using the Hologic Affirm prone biopsy system.

Feature | Breast Biopsy Systems | October 17, 2019 | By Harriet Borofsky, M.D.
The current body of research supporting...
Fujifilm Releases Tomosynthesis Biopsy Option for Aspire Cristalle Mammography System
Technology | Breast Biopsy Systems | July 24, 2019
Fujifilm Medical Systems U.S.A. Inc. recently expanded its breast imaging solutions with the launch of its...
Hologic Launches Trident HD Specimen Radiography System
Technology | Breast Biopsy Systems | April 26, 2019
Hologic Inc. announced global commercial availability of the Trident HD specimen radiography system. The next-...
The Cianna Medical Savi Scout Radar Localization system, showing the console, detector and the marker, with a size comparison and X-ray images inside breast tissue. For more information on the learning curve of its use http://sabcs16.posterview.com/nosl/p/P1-11-06.

The Cianna Medical Savi Scout Radar Localization system, showing the console, detector and the marker, with a size comparison and X-ray images inside breast tissue. For more information on the learning curve of its use http://sabcs16.posterview.com/nosl/p/P1-11-06.

Feature | Breast Imaging | April 24, 2019 | By Greg Freiherr
Wires have traditionally been placed prior to lumpectomy to mark cancerous tissues in the breast.
Novel Technique May Significantly Reduce Breast Biopsies
News | Breast Biopsy Systems | January 17, 2019
A novel technique that uses mammography to determine the biological tissue composition of a tumor could help reduce...
Philips’ Compressed SENSE technology helps shorten MRI exams by eliminating redundant radiofrequency signals from the acquisition phase. The software reconstructs any missing  information to maintain high image quality. (Images courtesy of Philips/University Hospital Cologne)

Philips’ Compressed SENSE technology helps shorten MRI exams by eliminating redundant radiofrequency signals from the acquisition phase. The software reconstructs any missing information to maintain high image quality. (Images courtesy of Philips/University Hospital Cologne)

Feature | Breast Imaging | November 05, 2018 | By Jeff Zagoudis
The incidence of breast cancer is rising globally, with an estimated 1 in 8 women diagnosed in their lifetime and 40,...
Leica Biosystems Launches MammoPort Specimen Containment and Transport System
Technology | Breast Biopsy Systems | October 03, 2018
Leica Biosystems announced the U.S. launch of MammoPort, the first integrated specimen containment and transport system...
The Magtrace and Sentimag Magnetic Localization System uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal. The FDA granted approval of the Sentimag System to Endomagnetics Inc.

The  Endomagnetics' Magtrace and Sentimag Magnetic Localization System uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal.

Technology | Women's Health | July 24, 2018
July 24, 2018 — The U.S.