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 competitive monitors.

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 HIMSS `99.

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.

Contact:

     Alliance Instruments
     Jay Pearce, 360/882-2601, [email protected]

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Thanks Anna!

Thanks Kinetic!