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:4/30/2016)... ... April 30, 2016 , ... The Hacking Medicine Institute ... to critically evaluate and rank health-focused applications and connected devices for better disease ... unbiased and accurate information to help accelerate patient and provider adoption of clinically ...
(Date:4/30/2016)... ... April 30, 2016 , ... Orlando-based Maximized Living has selected Dr. Nick Wilson ... Rio. Under the care of Maximized Living doctors at the London Olympics in ... Maximized Living is sending the largest contingent of elite chiropractors to Rio to support ...
(Date:4/29/2016)... ... 2016 , ... Memorial Healthcare System Graduate Medical Education ... that it has received accreditation for its residency program on Physical Medicine and ... Memorial is currently pursuing, including Pediatrics and Internal Medicine. This accreditation allows the ...
(Date:4/29/2016)... Torrance, CA (PRWEB) , ... April 29, 2016 ... ... physician advocating optimistic healthcare awareness and author of best seller "LOVE, MEDICINE and ... Talk Radio Monday, May 2, 2016 and podcasted thereafter . Dr. Bernie ...
(Date:4/29/2016)... ... April 29, 2016 , ... Spine Team Texas, a comprehensive spine physician group ... of their physicians has been invited to be a featured speaker at the Texas ... conference on April 30, 2016. , Dr. R. Scott McPherson, a physical medicine ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... April 27, 2016 The ... USD 2.06 billion by 2022, according to a ... consumer awareness towards a healthy lifestyle is expected ... years.      (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ... with rising health treatment expenditure has urged consumers ...
(Date:4/26/2016)... -- Diplomat Pharmacy, Inc. (NYSE: DPLO) is pleased to ... D., to Vice President of Education and Quality. ... continue to lead and oversee Diplomat University, an innovative ... training to Diplomat employees and external professionals on topics ... houses the quality assurance department, which focuses on programs ...
(Date:4/26/2016)... 2016 US demand for infection prevention ... percent annually to $27.6 billion in 2020.  Increasing ... decrease rates of healthcare-associated infections (HAIs) will boost ... services.  Although declining, the overall rate of certain ... set by the CDC.  Recent statistics indicate that ...
Breaking Medicine Technology: