Navigation Links
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.

About Naviscan, Inc.

Naviscan, founded in 1995, develops and markets compact, high-resolution PET scanners intended to provide organ-specific molecular imaging, guide radiological and surgical procedures and advance new clinical therapies. The Naviscan PET scanner is currently installed and available in breast and imaging centers throughout the U.S. as well as utilized in clinical research studies, funded in part by the National Institutes of Health.

The Company is headquartered in San Diego, California and is the first company to obtain FDA clearance of a high-resolution PET scanner designed to image small body parts. For more information, call 1.858.587.3641 or visit http://www.naviscan.com


'/>"/>
SOURCE Naviscan, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Naviscan PET Systems to Place High-Resolution PET Scanner at M. D. Anderson Cancer Center
2. Naviscan Announces a New Chairman and Board Member
3. Settlement Reached Between Dilon Technologies and Naviscan on Patent Rights
4. Naviscans PEM Flex(TM) Scanner Shows Promising New Data in Breast Cancer Management
5. Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem(R) Pulvules(R) Capsules
6. Capital BlueCross Receives Prestigious Corporation of the Year Award
7. Bmc nurse manager receives Abstract Award
8. Cancer researcher receives $3.8 million award from US Department of Defense
9. Virginia Mental Health Hospital Improves Patient Comfort, Receives Award for Energy-Saving Renovations
10. Graduate research scientist at Rutgers University in Newark receives honors
11. Idea to Arm Cancer Patients with Information Specific to Their Disease and Treatment Receives Nod, Grant from American Cancer Society
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/25/2017)... ... April 25, 2017 , ... ... the continuation of its strategic partnership with and platinum sponsorship of Global Spine ... the safe and effective management of complex spine deformity cases, particularly in children. ...
(Date:4/24/2017)... FLORIDA (PRWEB) , ... April 24, 2017 , ... ... telehealth technology yesterday, featuring Bring Your Own Device (BYOD) capabilities at Telehealth 2.0, ... LG CNS’ pre-packaged telehealth bundles, which pairs medical devices with a pre-programmed tablet ...
(Date:4/24/2017)... ... April 24, 2017 , ... The Santana Telehealth Project ... 2017: Telehealth 2.0 — the American Telemedicine Association’s annual conference, on April 23 in ... for using telemedicine to improve the lives of the poor and underserved in other ...
(Date:4/24/2017)... TX (PRWEB) , ... April 24, 2017 , ... As ... Memorial Museum today to honor the victims of the Holocaust and Nazi persecution, ... ceremonies at Hadamar and Auschwitz on its CMATH Champions trip to Germany and Poland ...
(Date:4/24/2017)... TX (PRWEB) , ... April 24, 2017 , ... The ... the glitterati, those unreal icons inhabiting the rarified air of pop and film stardom.(1) ... paparazzi and anyone snapping pictures: the smile. Grins now run the gamut from being ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... , April 20, 2017 Research ... "Global Biosimilar Pipeline and Market Prospects: Addressing Production Complexities ... to their offering. ... "Global Biosimilar Pipeline and Market Prospects: Overcoming ... provides an in-depth assessment of the current trends in ...
(Date:4/20/2017)... DUBLIN , April 20, 2017 Research ... Delivery Technologies - Innovation Driven by Rapidly Expanding Injectables Market and ... to their offering. ... market for drug delivery technologies will rise from USD 20 Billion ... Global Drug Delivery Technologies - Innovation Driven by Rapidly ...
(Date:4/20/2017)... BOSTON , April 20, 2017   ZappRx, Inc ... the specialty drug prescribing process, today announced it closed $25 ... Fund, a venture capital firm based in Seattle ... Qiming Venture Partners . The Series B round included ... A round in 2014, and GV (formerly Google ...
Breaking Medicine Technology: