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:9/19/2017)... ... September 19, 2017 , ... ... Mirixa Corporation recently unveiled the MirixaPro 6.0 platform. As the industry’s leading ... management services are delivered. Based on industry research and market feedback, the ...
(Date:9/19/2017)... (PRWEB) , ... September 19, 2017 , ... ... people searching for solutions to their neck and back pain with a reputable ... network. Allegion Spine Institute , formerly known as Nevada Spine Clinic was ...
(Date:9/19/2017)... ... September 19, 2017 , ... The ISO 9001 standard ... businesses and organizations become more efficient and improve customer satisfaction. ISO 9001:2015 was released ... own QMS, with a deadline of September 2018. , As described in ...
(Date:9/19/2017)... , ... September 19, 2017 ... ... DACVIM, a board-certified veterinary oncologist, has agreed to serve as strategic adviser ... Dr. Tripp is founder of the Bridge Animal Referral Center (BARC) ...
(Date:9/19/2017)... ... , ... Ron Norman, CEO of Team Decades, http://www.teamdecades.com , stressed to ... than generic impression in the job market if one is looking for career expansion. ... that the first impression they give off is not a good one," says Norman, ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... ALLENTOWN , Pa. and KALAMAZOO, Mich. ... Allentown, Penn. , and OptiMed Specialty Pharmacy ... a business partnership to offer a strategic hub service ... PMD Healthcare,s highly sought-after personal spirometer, Spiro PD 2.0, ... A spirometer is a medical device used ...
(Date:9/12/2017)... 12, 2017   EcoVadis , the leading platform for environmental, social ... annual edition of its Global CSR Risk and Performance Index. The report ... based on Scorecard Ratings that analyzed nearly 800,000 data points across the ... ... ...
(Date:9/9/2017)... ... ... Monday, September 18 th .The Brain Tumor Foundation (BTF) begins a week-long ... BTF,s Mobile MRI Unit – a 70 Ft. ... brings its nationwide initiative, the Road to Early Detection Sponsor-A-City Campaign to ...
Breaking Medicine Technology: