Healthcare Industry News: Tyco Healthcare
News Release - September 20, 2006
Medwave's Fusion(TM) Granted 510(k) Clearance by FDA
Pioneering vital signs monitor will be available to United States healthcare marketsDANVERS, Mass., Sept. 20 (HSMN NewsFeed) -- Medwave Inc. (Nasdaq: MDWV ), the innovator in sensor-based, non-invasive blood pressure measuring solutions, announced today that it has received clearance by the U.S. Food and Drug Administration (FDA) to market Fusion(TM), 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."
The launch of Fusion(TM) 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. For more information, visit http://www.medwave.com .
Statements made in this release that are stated as expectations, plans, anticipations, prospects or future estimates or which otherwise look forward in time are considered "forward-looking statements" and involve a variety of risks and uncertainties, known and unknown, which are likely to affect the actual results. The following factors, among others, as well as factors discussed in Medwave's filings with the SEC, have affected and, in the future, could affect Medwave's actual results: resistance to the acceptance of new medical products, the market acceptance of the Fusion(TM) system, the Primo® system, the Vasotrac® system and other products of Medwave, hospital budgeting cycles, the possibility of adverse or negative results or commentary from clinical researchers or other users or evaluators of Medwave's products, Medwave's success in creating effective distribution channels for its products, Medwave's ability to scale up its manufacturing process, and delays in product development or enhancement or regulatory approval. Consequently, no forward-looking statement can be guaranteed and actual results may vary materially. Medwave®, Vasotrac®, Legato®, Primo®, and Fusion(TM) are trademarks of Medwave, Inc.
Source: Medwave
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