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Aspect Medical Systems Receives FDA Clearance for Next Generation BIS XP Monitoring Systems.


Business/Technology Editors & Health/Medical Writers

NEWTON, Mass.--(BUSINESS WIRE)--June 25, 2001

-Technology Offers Expanded Performance During Procedures

Requiring Electrocautery-

Aspect Medical Systems, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ASPM ASPM Abnormal Spindle-Like Microcephaly Associated
ASPM Asociación del Secretariado Profesional de Madrid (Spanish: Association of the Professional Secretaryship of Madrid)
ASPM Armed Services Procurement Regulation Manual
) has received 510(k) clearance from 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.
) for BIS(R) XP Monitoring Systems, announced Nassib Chamoun, president and 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.  of the Newton-based medical device manufacturer. The BIS XP technology will provide a number of enhancements for the A-2000(TM) BIS Monitor and BIS Modules to enable expanded performance capabilities for consciousness monitoring.

Used with the recently released BIS Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 Sensor or BIS Sensor XP, the new BIS XP monitoring systems offer increased resistance to electrocautery electrocautery /elec·tro·cau·tery/ (-kaw´ter-e) an apparatus for surgical dissection and hemostasis, using heat generated by a high-voltage, high-frequency alternating current passed through an electrode.  artifact, enhanced performance in deep anesthetic states, and improved robustness to interference from noise sources, such as high frequency motion artifact which occurs in the operating room operating room
n. Abbr. OR
A room equipped for performing surgical operations.
 and intensive care unit.

"This latest advance reflects Aspect's ongoing commitment to continuously increase the value of BIS technology to the thousands of anesthesia providers who have adopted it," said Chamoun. "Based on feedback from customers and experience from monitoring more than three million patients, we were able to refine our technology and raise the standard of performance in consciousness monitoring equipment. The enhanced functionality provided by BIS XP systems will enable healthcare providers to better meet the needs of their patients in the operating room, the intensive care unit, or in procedure rooms where sedation Sedation Definition

Sedation is the act of calming by administration of a sedative. A sedative is a medication that commonly induces the nervous system to calm.
Purpose

The process of sedation has two primary intentions.
 is administered."

About Aspect Medical Systems, Inc.

Aspect Medical Systems, Inc. is the pioneer and world leader of consciousness monitoring technologies that provide information about patient status to empower clinicians to advance the quality and safety of patient care. Leading institutions around the country have advanced the standard of care by providing patient access to BIS technology. To date, more than 11,100 BIS monitors have been installed in operating rooms and at ICU ICU intensive care unit.

ICU
abbr.
intensive care unit



ICU

see intensive care unit.

ICU 
 bedsides, and more than three million patients have been monitored throughout the world. BIS technology has been licensed for integration into patient monitoring systems for Agilent Technologies, Datex-Ohmeda, Draeger, GE Medical Systems Information Technologies, Nihon Kohden and Spacelabs Medical. For more information, visit the company's web site at http://www.aspectms.com.

Certain statements about Aspect in this release and on Aspect's Web site are forward-looking and may involve risk and uncertainties, including statements with respect to benefits of, and demand and market acceptance for Aspect's products and Aspect's competitive position. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are the results of clinical trials, market acceptance of products and products under development, regulatory approval of products under development, the scope of Aspect's patent protection and other risks included under the heading, "Factors Affecting Future Operating Results," in Aspect's annual report on Form 10-Q Form 10-Q

See 10-Q.
 for the fiscal quarter ended March 31, 2001 filed on May 14, 2001, with the Securities and Exchange Commission.

Bispectral Index and BIS are registered trademarks of Aspect Medical Systems, Inc. A-2000 is a trademark of Aspect Medical Systems, Inc.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jun 25, 2001
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