Criticare Systems, Inc. Announces Receipt of FDA 510k Approval to Market a New, Advanced Design, Portable Monitor
August 16 2005 - 2:01PM
Business Wire
CRITICARE SYSTEMS, INC. (AMEX:CMD). Criticare Systems, Inc. today
announced that on August 16, 2005 the company received FDA approval
to market its new portable cardiac monitor. This advanced system is
intended to monitor physiological parameters of patients within any
healthcare environment. The unique design allows a wide variety of
optional configurations so it can be tailored for specific market
requirements. Criticare developed this product line to be marketed
on a worldwide basis where it is important to offer system
differentiation to meet the needs of a particular clinical
environment. Among the unique features of the new system is the
incorporation of certain popular oxygen saturation and temperature
measurement technologies as options to satisfy specific clinical
and economic requirements. The company believes this system
represents a significant advancement in the capturing of important
physiological data in a rapid, flexible manner. The system will be
market launched during Criticare's current fiscal quarter.
Criticare (www.csiusa.com) designs, manufactures, and markets
cost-effective patient monitoring systems and noninvasive sensors
for a wide range of hospitals and alternate health care
environments throughout the world. This press release contains
forward-looking statements. Such statements refer to the Company's
beliefs and expectations. Forward-looking statements are subject to
certain risks and uncertainties that could cause actual results to
differ materially from those described. Such uncertainties include,
but are not limited to, the timely completion of new products,
regulatory approvals for new products, the risk of new and better
technologies, risks relating to international markets, as well as
general conditions and competition in the company's markets. Other
risks are set forth in Criticare's reports and documents filed from
time to time with the Securities and Exchange Commission.
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