Physiometrix, Inc., Announces FDA Clearance Of Its Next Generation Monitor
February 10 2004 - 8:00AM
PR Newswire (US)
Physiometrix, Inc., Announces FDA Clearance Of Its Next Generation
Monitor NO. BILLERICA, Mass., Feb. 10 /PRNewswire-FirstCall/ --
Physiometrix, Inc. announced today that it has received clearance
from the Food and Drug Administration (FDA) for commercial
distribution of its PSA 5000 next generation monitor. 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
company anticipates launch of the product through its exclusive
distribution partner, Baxter Healthcare, later this year. "This
very rapid response by FDA reflects positively on the strength of
our regulatory team at Physiometrix and we are most enthusiastic
about the potential of our new next generation monitor," said John
A. Williams, president and chief executive officer. "This
innovative new platform allows level of consciousness monitoring to
be done conveniently anywhere in the hospital setting, including
the operating room and intensive care unit. Feedback from
clinicians has been superlative and we eagerly await the launch
with our partners at Baxter Healthcare," Williams concluded.
Designed for use by anesthesiologists, the PSA 4000 / 5000 is a
device that enables an anesthesiologist to monitor and manage a
patient's level of consciousness under anesthesia in the operating
room and intensive care unit. The PSA 4000 / 5000 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, Physiometrix Inc., +1-978-670-2422
Web site: http://physiometrix.com/
Copyright
Physiometrix (NASDAQ:PHYX)
Historical Stock Chart
From May 2024 to Jun 2024
Physiometrix (NASDAQ:PHYX)
Historical Stock Chart
From Jun 2023 to Jun 2024