Navigation Links
Intact Medical Corporation's Intact(R) Excise XL Receives 510(K) Marketing Clearance from the FDA
Date:9/16/2008

NATICK, Mass., Sept. 16 /PRNewswire/ -- Intact Medical Corporation, an emerging leader in the development and marketing of minimally invasive systems for the diagnosis and removal of breast lesions, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Intact (R) Excise XL - a larger version of the Company's already FDA approved wands, used with the Intact (R) Breast Lesion Excision System (BLES). The Company expects to begin marketing the product to physicians in the fourth quarter of this year.

As with the Intact (R) BLES, the Intact (R) Excise XL procedure involves the insertion of a slender wand through a small incision in the breast to remove an intact sample of suspicious tissue for histopathologic analysis. The procedure can be performed in an office-based or outpatient setting, with the actual capture of the breast lesion completed in less than 20 seconds. To date, over 30,000 Intact (R) BLES procedures have been performed in the U.S. and Europe.

Christopher Bleck, President and Chief Executive Officer of Intact Medical, noted, "With the recent FDA clearance, the Intact (R) Excise XL represents an important line extension, providing greater choice for physicians and patients. Since it allows for extraction of larger, intact breast tissue, it has the potential to provide both a more accurate histopathologic assessment and the complete excision of even larger suspicious lesions. The Excise XL, with its larger capture basket, is a first-line alternative to surgical excision for any suspicious lesion 1.5cm (or smaller) in diameter. Under stereotactic or ultrasound image guidance, the Excise XL permits surgeons to completely excise small lesions along with the potential to evaluate tissue margins in a single, minimally-invasive procedure."

Mr. Bleck continued, "There are over 400,000 surgical breast procedures (excisional biopsies) for initial diagnostic purposes and more than 700,000 ben
'/>"/>

SOURCE Intact Medical Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. AEterna Zentaris completes management team with the appointment of Chief Medical Officer
2. VisEn Medical Files Action to Invalidate New Caliper Life Sciences Patent
3. China Medical Technologies to Participate in the Morgan Stanleys 2007 China Medical Corporate Day
4. Pathway Medical Technologies Adds Joe Rafferty as VP, Sales, and Moves To Larger Facility to Accommodate Rapid Growth
5. BioMS Medical announces its intention to renew a normal course issuer bid
6. Dr. Amit Dhawan Promoted to Medical Director for The Mattson Jack Group
7. ATS Medical Expands Open Pivot Heart Valve Offerings
8. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
9. Globus Medical Announces Record 2nd Quarter 2007 Results
10. IDM Pharma Names Dr. Jeffrey W. Sherman Chief Medical Officer and Senior Vice President of Research and Development
11. China Medical Technologies Reports First Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... and BOSTON , Oct. ... ), a leading global specialty pharmaceutical company, and Rhythm, ... granted an exclusive option to acquire Rhythm,s wholly owned ... a peptide ghrelin agonist, for the treatment of diabetic ... Rhythm has completed a successful Phase 2 trial of ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 WriteResult, ... services – has been working with a team of ... New Haven Farms Community Farming Collaborative to provide electronic ... solution. The study, which started in May, aims ... that provides participants weekly exposure to and participation in ...
(Date:10/22/2014)... Md. , Oct. 22, 2014   Synthetic ... developing novel pathogen-specific therapies for serious infections and diseases, ... has issued a Notice of Allowance for a composition ... its C. difficile program, SYN-004. This is ... SYN-004 in the U.S. and adds to the Company,s ...
(Date:10/20/2014)... The report “Pharmacy Automation Systems ... and Labeling Systems, Table-top Counters) by End-user (Inpatient ... & Trends to 2019” analyzes and studies the ... America, Europe, Asia-Pacific, and the Rest of the ... 30 figures spread through 300 pages and in-depth ...
Breaking Biology Technology:Actavis Signs Option to Acquire Rhythm Subsidiary and its GI Development Product, Relamorelin 2Actavis Signs Option to Acquire Rhythm Subsidiary and its GI Development Product, Relamorelin 3Actavis Signs Option to Acquire Rhythm Subsidiary and its GI Development Product, Relamorelin 4Actavis Signs Option to Acquire Rhythm Subsidiary and its GI Development Product, Relamorelin 5myPROpad™ Topic of Panel Discussion at the Yale Food Systems Symposium 2myPROpad™ Topic of Panel Discussion at the Yale Food Systems Symposium 3Synthetic Biologics Announces Allowance of Key U.S. Composition of Matter Patent for C. difficile Program 2Synthetic Biologics Announces Allowance of Key U.S. Composition of Matter Patent for C. difficile Program 3Synthetic Biologics Announces Allowance of Key U.S. Composition of Matter Patent for C. difficile Program 4Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 2Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 3Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 4
... , June 25, 2010 Industrial biotechnology ... per year through 2020. Germany ,has already established ... industry, making it an ideal site for,companies looking to ... Invest will be on hand at this year,s World ...
... German . , Organic semiconductors are very ... large area and flexible electronic components such as transistors, diodes ... A condition for success in achieving this goal is the ... in other words, to create an electronic circuit. Empa scientists ...
... ... Company) proffered his views of outsourcing product development trends as they pertain to the design ... science association in the world. , ... Irvine, CA, USA (PRWEB) June 23, 2010 -- BIT Group has ...
Cached Biology Technology:Market Demand and Innovation in Germany Propel Industrial Biotechnology Growth 2Market Demand and Innovation in Germany Propel Industrial Biotechnology Growth 3Nanowires for the electronics and optoelectronics of the future 2Nanowires for the electronics and optoelectronics of the future 3BIT Group Executive Featured in BioTechnology Series 2BIT Group Executive Featured in BioTechnology Series 3
(Date:10/15/2014)... and to an unexpected extent. The outbreak does not ... virus shows a new disease dynamic in regions, where ... the German National Academy of Sciences Leopoldina, acatech – ... Union of the German Academies of Sciences and Humanities ... , In the statement the academies call for the ...
(Date:10/14/2014)... discriminating thieves, prostate cancer tumors scavenge and hoard copper ... such avarice may be a fatal weakness. , ... kill prostate cancer cells by delivering a trove of ... diseased cells brimming with the mineral, leaving non-cancer cells ... already commercially available for other uses, could soon be ...
(Date:10/14/2014)... research team has discovered a new kind of stem cell ... that lines liver blood vessels, according to a study published ... existence of such a cell type contradicts current theory on ... may hold clues to origins of, and future treatment for, ... single cell into a complex being made up of more ...
Breaking Biology News(10 mins):Academies call for consequences from the Ebola virus epidemic 2Academies call for consequences from the Ebola virus epidemic 3Academies call for consequences from the Ebola virus epidemic 4Academies call for consequences from the Ebola virus epidemic 5Prostate cancer's penchant for copper may be a fatal flaw 2Stem cell discovery challenges dogma on how fetus develops; holds insights for liver cancer and reg 2Stem cell discovery challenges dogma on how fetus develops; holds insights for liver cancer and reg 3
... change in recent decades, but species have adapted to this, ... red deer and wild boar. This has been shown ... in land use on the past, present and future distribution ... has been an increase in the area of distribution of ...
... of biomedical informatics in the Institute for Translational Sciences ... was recently honored for using advanced visual analytical methods ... along with an interdisciplinary team that included ITS director ... Ju and Sundar Victor, received a Distinguished Paper Award ...
... When you think you see a face in the clouds or ... be upside down. It turns out the answer to this ... to. Using tests of visual perception and functional magnetic resonance ... Ontario,s world-renowned Centre for Brain & Mind recently measured activity in ...
Cached Biology News:Changes in land use favor the expansion of wild ungulates 2UTMB's Bhavnani wins award for cutting-edge research in translational bioinformatics 2
... inL10 Workstation from Caliper represents a revolutionary ... the first time the ability to generate ... to changing conditions. In addition, each ... due to changes in temperature, and offers ...
... fully automated systems for a broad range ... for applications ranging from compound logistics, over ... screening, which means it has fully automated ... and follow up studies all at your ...
ID clarifier: non-treated with lid...
... Building on over 20 years of experience ... the Life Sciences, the Freedom EVO platform ... expansion according to future needs. Together with ... system is equipped to successfully operate genomics, ...
Biology Products: