Physiometrix Files 510(k) with FDA For Next Generation Monitor
January 08 2004 - 8:00AM
PR Newswire (US)
Physiometrix Files 510(k) with FDA For Next Generation Monitor NO.
BILLERICA, Mass., Jan. 8 /PRNewswire-FirstCall/ -- Physiometrix,
Inc. (NASDAQ-SCM: PHYX) announced today that it has submitted a
510(k) application to obtain clearance for commercial distribution
of its PSA 5000 next generation monitor to the U.S. Food and Drug
Administration (FDA). The PSA 5000 is a new state of the art
monitor that is more powerful, cost effective and ergonomic than
it's predecessor the PSA 4000. "The conclusion of this development
effort represents a significant step forward for Physiometrix,"
said John A. Williams, president and chief executive officer. "We
believe this next generation technology, with several new features,
will further differentiate us from our competition. With clinical
studies being readied for distribution and a new marketing and
sales focus with our Partners at Baxter, we believe that we are
well positioned for success and 2004 will be a strong year for our
company." Designed for use by anesthesiologists, the PSA 4000 is a
device that enables an anesthesiologist to monitor and manage a
patient's level of consciousness under anesthesia in the operating
room or intensive care unit. The PSA 4000 has the potential to
enhance patient care and improve recovery times in hospitals across
the U.S. and around the world. Physiometrix, Inc. designs,
manufactures and markets noninvasive medical products -- based on
novel gel materials, sophisticated signal-processing electronics
technologies, and proprietary software -- for use in anesthesia-
monitoring during surgical procedures. Safe Harbor Statement
Statements in this press release regarding Physiometrix's growth
and future business results of the Company are "forward-looking"
statements as defined in the Private Securities Litigation Reform
Act of 1995. Such statements are based upon management's current
expectations and are subject to a number of factors and
uncertainties. Information contained in these forward-looking
statements is inherently uncertain, and actual performance and
results may differ materially due to many important factors. Such
factors that could cause actual results to differ materially from
any forward-looking statements made by the Company include, among
others, revenue estimates, dependence on existing and future
products, uncertainty of market acceptance, intense competition,
partnership agreements, and government regulations, especially
regulatory approvals. Other relevant risks are described in the
Company's Form 10-K filed March 28, 2003 and Form 10Q dated
November 14, 2003, with the SEC. CONTACT: Daniel W. Muehl, CFO
Physiometrix Inc. 978-670-2422 DATASOURCE: Physiometrix, Inc.
CONTACT: Daniel W. Muehl, CFO of Physiometrix Inc., +1-978-670-2422
Web site: http://physiometrix.com/
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