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Medwave's FusionTM Granted 510(k) Clearance by FDA

by Barbara Kram, Editor | October 01, 2006
Medwave, Inc. Danvers, MA (NASDAQ: MDWV) - Medwave, Inc., the innovator in sensor-based, non-invasive blood pressure measuring solutions, has received clearance by the U.S. Food and Drug Administration (FDA) to market FusionTM, the first completely sensor-based blood pressure with vital signs options monitor.

Fusion is a non-invasive blood pressure measurement device, built around Medwave's core sensor-based blood pressure technology, which takes readings at the wrist. Medwave's core technology has been the subject of numerous independent clinical validation studies, and results have shown that accuracy is comparable to an invasive arterial catheter. Fusion takes Medwave's core technology one step further by incorporating proven, sensor-based pulse oxymetry by Nellcor and thermometry by Kendall (both operating companies of Tyco Healthcare Group LP), creating a complete, non-invasive, vital signs solution.

"Fusion represents a turning point in the way health providers care for their patients," said Medwave CEO Tim O'Malley. "They now have a device to continually monitor vital signs without invasive techniques. That's something we never could have imagined 30 years ago."
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The launch of FusionTM follows on the heels of the recent launch of Primo©, a portable, handheld blood pressure monitor that is currently in use at hospitals and clinics nationwide. Medwave recently announced distribution agreements with Tri-anim and McKesson for Primo. Like Primo, Fusion's sensor-based technology means that it is highly accurate, and can monitor patients with 11-22cm wrist sizes.

"There is nothing like this on the market. Period." Added O'Malley. "Our sensor-based technologies represent an important step toward creating a better, easier and more comfortable healthcare experience for patients. No cuff, no catheter, no kidding. That's us."

About Medwave
Medwave, Inc. develops, manufactures and distributes sensor-based non-invasive blood pressure solutions. Medwave's suite of products is designed for use in hospitals, clinics, doctor's offices and almost anywhere blood pressure monitoring occurs. Medwave has the required technology clearances to market its technology in the United States, Europe and Asia. Medwave's technology is installed in more than 500 hospitals and clinics worldwide. Medwave trades on the NASDAQ small cap market under the symbol MDWV.