Printer Friendly
The Free Library
19,604,538 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

CellTracks(R) Analyzer II Receives FDA 510(k) Clearance for Linux-Based Software.


HUNTINGDON VALLEY, Pa. -- Immunicon Corporation (NASDAQ-NM:IMMC IMMC Illinois Masonic Medical Center
IMMC Integrated Materiel Management Center
IMMC Intelligence Materiel Management Center
IMMC Interdigestive Migrating Motor Complex
IMMC International Meeting on Mine Clearance (UN) 
) announced today that Linux-based software for the CellTracks(R) Analyzer II was cleared by the U.S. Food and Drug Administration for in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
 diagnostic use through the 510(k) process. The CellTracks Analyzer II is currently sold with XP-based software for counting and characterizing circulating cir·cu·late  
v. cir·cu·lat·ed, cir·cu·lat·ing, cir·cu·lates

v.intr.
1. To move in or flow through a circle or circuit: blood circulating through the body.

2.
 tumor tumor: see neoplasm.  cells CTCs, which predict survival in patients with metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 breast cancer. The new software provides an improved user interface and data management, faster scanning time and more flexibility in analysis of CTCs.

Immunicon Corporation

Immunicon Corporation is developing and commercializing proprietary cell-based research and human diagnostic products with an initial focus on cancer disease management. The company has developed platform technologies for selection and analysis of rare cells in blood, such as circulating tumor cells. Immunicon's products and underlying technology platforms also have application in the clinical development of cancer drugs and in cancer research, and may have application in other fields of medicine, such as cardiovascular and infectious diseases infectious diseases: see communicable diseases. . http://www.immunicon.com

The information contained in this press release includes "forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. These forward-looking statements are often preceded by words such as "hope," "may," "believe," "anticipate," "plan," "expect," "intend," "assume," "will" and similar expressions. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Forward-looking statements speak only as of the date of this press release, reflect management's current expectations and involve certain factors, such as risks and uncertainties that may cause actual results to be far different from those suggested by the Company's forward-looking statements. These factors include, but are not limited to, risks associated with: the Company's dependence on Veridex, LLC (Logical Link Control) See "LANs" under data link protocol.

LLC - Logical Link Control
; the Company's capital and financing needs; research and development and clinical trial expenditures; commercialization of the Company's product candidates; the Company's ability to use licensed products and to obtain new licenses from third parties; the Company's ability to manage its growth; obtaining necessary regulatory approvals; reliance on third party manufacturers and suppliers; reimbursement Reimbursement

Payment made to someone for out-of-pocket expenses has incurred.
 by third party payors to the Company's customers for the Company's products; compliance with applicable manufacturing standards; the ability to earn license and milestone payments under the Company's agreement with Veridex; retaining key management or scientific personnel; delays in the development of new products or to planned improvements to the Company's products; effectiveness of the Company's products compared to competitors' products; protection of the Company's intellectual property and other proprietary rights; conflicts with the intellectual property of third parties; product liability lawsuits that may be brought against the Company; labor, contract or technical difficulties; and competitive pressures in the Company's industry. These factors are discussed in more detail in the Company's filings with the Securities and Exchange Commission.

"Immunicon" and the Immunicon Corporation logo are registered trademarks of Immunicon Corporation. "CellSpotter" and "CellTracks" are registered trademarks of Immunivest Corporation, a wholly-owned subsidiary of Immunicon Corporation. "CellSearch" is a trademark of Johnson & Johnson. ALL RIGHTS RESERVED.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Mar 22, 2006
Words:497
Previous Article:NWHF Announces New Fellowship to Support Autism Research.
Next Article:Fitch Expects to Rate Rental Car Finance Corp., Asset-Backed Notes, Series 2006-1 'AAA'.
Topics:



Related Articles
Approval processes different for devices and drugs.
Base Ten receives two 510(k) Premarket Notification clearances from FDA.
Radionics Announces Two FDA Clearances - One for its XPlan System to Assist in Treatment of Brain Tumors, and Clearance of the Cosman Coagulator.
LifeShirt.com Obtains FDA 510'k' Clearance For Core Monitoring Software.
APPLIED BIOSYSTEMS/BRAZILIAN NMH SIGN PACT FOR GENOTYPING.
IGENEON AND IMMUNICON FORM DEVELOPMENT ALLIANCE.
Infineon Technologies, Samsung Electronics, Trolltech and Emuzed intro first Linux UMTS/EDGE dual-mode smartphone reference design.
Immunicon's CellTracks(R) Analyzer II Wins Medical Design Excellence Award.
Immunicon Achieves Endpoints in its Pivotal Clinical Trial in Metastatic Colorectal Cancer.
Smiths Medical Launches New Medication Safety Software.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles