Tuesday March 23, 6:06 pm Eastern Time
Company Press Release
FDA Gives 510K Approval to integriti, a New Portable Patient Monitoring System from Alliance Instruments
VANCOUVER, Wash.--(BUSINESS WIRE)--March 23, 1999--Alliance
Instruments, a maker of point-of-care devices, announced today that
its integriti system has received 510K approval from the U.S. Food and
Drug Administration (FDA).
The approval clears the way for the sale of the innovative
product, the first to provide Windows-based portable monitoring and
bedside management of patient information.
Alliance Instruments has developed the integriti system as
hospitals are delivering more care in sub-acute and step down
settings, and there is need for comprehensive monitoring in
environments ranging from emergency transport to preoperative care
units. This trend requires monitoring solutions that are less costly
to purchase; are smaller, lighter and more durable; and can present a
wider range of vital signs and trend data as well as provide access to
other essential clinical information.
Designed by many of the same engineers who introduced
ultraportable monitors in the 1980s, integriti sets new standards for
usability and dependability. With a unique component packaging
approach, the unit boasts a low weight and exceptional ruggedness that
bed side care-givers will appreciate. Its high resolution, active
matrix color display (with simple touchscreen control) allows for easy
viewing from any angle. Finally, an innovative power management system
gives integriti an operational time as much as 50 percent longer than
To support timely and fact-based bedside clinical decision
making, integriti provides for full vital signs monitoring, and the
simultaneous automatic downloading of monitored results into the
electronic patient record or other clinical applications. Offering
automated profiling (screen setup) in any clinical setting, integriti
monitors noninvasive blood pressure, Sp02, 30-second temperature and
ECG and two invasive blood pressures if needed. Optionally, it
provides a C02 input and full graphics strip recording capability.
The high performance and range of capability of integriti result
from its use of an embedded, industry-standard PC, as well as a
Windows-based operating system and a high speed wireless communication
subsystem. These elements position integriti for use in highly
interconnected healthcare networks in which clinical information is
accessible at any point of care.
With the 510K approval, Alliance is set to begin volume
production of integriti, with initial shipments slated for late 1999.
In addition, the company is now moving to activate the strategic
partnerships it has been putting in place since it previewed integriti
to the industry at the 1998 HIMSS conference. Included is a leading
U.S. health system integrator with which Alliance presented
integriti's unique Windows capabilities in joint demonstrations at
When released for sale later this year, integriti will be list
priced at less than any competitive portable monitor in its class. The
system will be backed by a limited lifetime warranty, and Web-based
technical support will be available.
Alliance Instruments is a five year-old, privately held company
based in Vancouver, Washington. Its mission is to develop and market
high quality ultraportable monitors and related medical devices that
deliver significantly higher price/performance value than do
competitive systems. Each of the members of the Alliance management
team has more than 20 years experience in the development of medical
products and related health care applications.
Jay Pearce, 360/882-2601, [email protected]
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