Barnev Inc. Announces FDA Approval Of The Computerized Labor Monitoring System (CLM)
NETANYA, Israel--(BUSINESS WIRE)--Barnev Inc. announced today that the U.S. Food and Drug Administration (FDA) 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 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 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, should such a situation arise,” said Barnev Inc. CEO 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 (SMFM) meeting on February 7, 2007 at the San Francisco Hilton & Towers in San Francisco, California.
“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.
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 firstname.lastname@example.org or at +972-54-536-5220 .
For Barnev Inc. Naama Zamir, +972-9-8923130 www.barnev.com or
Media Liaison Marjie Hadad, +972-54-536-5220 email@example.com