Healthcare Industry News:  blood glucose 

Devices FDA

 News Release - March 31, 2006

Hypoguard Receives 510(k) Clearance to Market Assure(R) Pro Blood Glucose Monitoring System

New full-featured blood glucose system designed specifically for Long-Term Care

MINNEAPOLIS, March 31 (HSMN NewsFeed) -- Hypoguard announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Assure® Pro blood glucose Monitoring System.

Assure® Pro is specifically designed for multi-resident use in long-term care (LTC) facilities. This full-featured system offers qcProGuard(TM), the first of its kind, 24-hour reminder to conduct daily control solution testing as required in LTC settings. A "Hypo" warning alerts users of low blood glucose readings and four programmable alarms can be used as test reminders. Assure Pro Test Strips are built using platinum technology and require a small blood sample size (1 uL). To test, simply insert the test strip in the convenient top-of-the-meter port. Results are displayed in 10 seconds on a large LCD and a backlight display (adjustable) assists for reading in low light conditions. A strip release button for strip disposal eliminates the need to touch a used strip, reducing the risk of exposure to infectious materials. For additional security, Assure Pro is designed with ProGrip(TM) to help secure a hold on the meter and reduce slipping on surfaces.

"Our expertise has always been in LTC and we are very excited to launch the Assure Pro System into our core market," said Dave Conn, President of Hypoguard USA. "Many of the features in this system were designed based on feedback from healthcare professionals. This innovative, easy-to-use, and full-featured blood glucose system meets the diverse needs of healthcare workers. We expect this to become the premier product in LTC."

The Assure Pro blood glucose Monitoring System will be available in April 2006.

About Hypoguard USA

Hypoguard ( ) is a leading healthcare company specializing in diagnostic products and medical devices at the point of care. Hypoguard develops, manufactures and markets innovative diagnostic products and related medical devices used in managing chronic diseases such as diabetes, screening for acute conditions utilizing blood and urine diagnostics, and enhancing healthcare worker safety. The company's primary products include a broad line of blood glucose monitoring systems, safety lancets and lancing devices, as well as urine testing equipment and supplies. Hypoguard's focus is to improve today's technology to develop products that are even more convenient and safe.

Source: Hypoguard

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