MedSearch, Announces Successful Completion of Initial Clinical Trials for Depth of Anesthesia Monitor
FDA 510K ruling for Depth of Anesthesia Monitor is expected shortly
NEW YORK--(BUSINESS WIRE)--Jan. 26, 1999-- MedSearch, Inc. (OTC BB: MDSX) today announced that initial clinical tests for the Depth of Anesthesia Monitor have been completed successfully.
The Company expects to have the final protocol according to FDA requirements within fifteen days. Additionally, the Company has procured the services of FDA expert Shosh Friedman. Friedman is certified by the Regulatory Affairs Professional Society (RAPS) and has extensive experience in preparing and supporting the execution of regulatory strategies for obtaining market clearance for medical devices including Premarket Notification (FDA 510K).
Friedman expects the Depth of Anesthesia Monitor to receive FDA clearance under the 510K ruling, an expeditious edict that should take approximately 90 days. Dr. Ofer Barnea, developer of the Depth of Anesthesia Monitor, has said ''Working in collaboration with Ms. Friedman has assured me that all of the steps we have taken are in accordance with FDA requirements.''
Jacob Meller, President and Chairman of MedSearch, stated, ''Receipt of the 510K clearance will allow us to bring this monitor to the US market in the near future. I am very excited for all those patients who will be going into surgery with peace of mind. We have made a difference.''
This release may contain forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the Company's expectations as a result of risk factors discussed in the Company's reports on file with the U.S. Securities and Exchange Commission.
More Quotes and News: MedSearch, Inc. (OTC BB:MDSX- news) Related News Categories: medical/pharmaceutical
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Contact:
MedSearch, Inc.
Frieda Goldstein, Vice President
212/943-6000
fgoldstein@medsearch1.com
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