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Barnev Inc. Announces FDA Approval of the Computerized Labor Monitoring System (CLM).


Company to launch CLM CLM - Career Limiting Move  at the SMFM SMFM Society for Maternal-Fetal Medicine
SMFM Synthetic Multifunctional Material
 meeting on February 7, 2007 in San Francisco

NETANYA, Israel -- Barnev Inc. announced today that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has cleared the company's new computerized labor monitoring system, the CLM, for use in the active stage of labor. The device continuously measures cervical dilation and fetal head station. These measurements are displayed real time both numerically and graphically, enabling the medical team to act based on timely information.

To date, the traditional procedure for monitoring the progress of labor is through vaginal examination, by insertion of the fingers towards the cervix. These examinations are intrusive and uncomfortable for the birthing mother and at best produce subjective data.

"A multi-center clinical trial, conducted internationally including in The United States, has shown the CLM to be an effective and accurate tool in monitoring the progress of labor. We are confident that the CLM will help obstetricians and midwives make truly informed decisions during labor, expedite their decision making process and potentially reduce the various risks of delivery," said Dan Farine, M.D., a professor of Ob/Gyn at the University of Toronto Research at the University of Toronto has been responsible for the world's first electronic heart pacemaker, artificial larynx, single-lung transplant, nerve transplant, artificial pancreas, chemical laser, G-suit, the first practical electron microscope, the first cloning of T-cells,  and head of Barnev's medical advisory board.

The CLM is an innovative labor progression monitoring system based on proprietary ultrasound technology. Signals from disposable, delicate sensors, positioned at the maternal cervix and fetal head, continuously track cervix dilatation dilatation /dil·a·ta·tion/ (dil?ah-ta´shun)
1. the condition, as of an orifice or tubular structure, of being dilated or stretched beyond normal dimensions.

2. the act of dilating or stretching.
 and fetal head descent. The CLM automatically transfers and processes the data, and instantly delivers the results on a user friendly monitor. The CLM's continuous data provides the delivery team with the necessary information to determine labor progression, thus facilitating a safer delivery. The system also increases patient convenience by limiting the number of intrusive and unpleasant vaginal examinations throughout the labor process.

"The CLM enables a simple, efficient and cost effective management of deliveries. In addition, the data collected by the CLM can be introduced in litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
, should such a situation arise," said Barnev Inc. CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  Mr. Yossi Machtey.

Barnev also announced today that the official market launch of the CLM will take place at the 27th Annual Meeting of the Society for Maternal-Fetal Medicine The Society for Maternal-Fetal Medicine (SMFM), located in Washington, DC, is a not-for-profit organization of over 2,000 members that are dedicated to improving perinatal care.  (SMFM) meeting on February 7, 2007 at the San Francisco Hilton & Towers in San Francisco, California “San Francisco” redirects here. For other uses, see San Francisco (disambiguation).

The City and County of San Francisco (EN IPA: [sænfrənˈsɪskoʊ] 
.

"We are enthusiastic about this launching event at the SMFM, culminating seven years of intensive effort in research, development and clinical trials. The CLM will be exhibited at Barnev's booth, number 209," said Mr. Machtey.

About Barnev

Barnev Inc. is a Delaware corporation with an R&D facility (Barnev Ltd.) in Israel. The company is engaged in the development, production and marketing of obstetric medical devices. For further information, please visit www.barnev.com or call Naama Zamir at +972-9-8923130. To schedule an interview or an appointment with CEO Mr. Yossi Machtey, please contact Marjie Hadad, media liaison, at marjie@netvision.net.il or at +972-54-536-5220.
COPYRIGHT 2007 Business Wire
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Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Feb 5, 2007
Words:477
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