Healthcare Industry News: Pulse Oximetry
News Release - June 13, 2006
Medwave Announces the Submission of Fusion(TM) to Food and Drug Administration for 510(k) ReviewDANVERS, Mass., June 13 (HSMN NewsFeed) -- Medwave, Inc. (Nasdaq: MDWV ), the innovator in sensor-based, non-invasive blood pressure measuring solutions, announced today that it has submitted a 510(k) application to the United States Food and Drug Administration for its Fusion(TM) Non-Invasive Patient Monitor System with Vital Signs Options.
Medwave, in conjunction with staff members at the University of Minnesota Medical Center, Fairview in Minneapolis, Minnesota have completed the necessary clinical validation studies with the Fusion product. These clinical validation studies were conducted according to the applicable standards that provide performance criteria for non-invasive blood pressure equipment and vital signs monitoring products.
Tim O'Malley, President and CEO of Medwave, Inc., stated, "We are happy to be at this point with the Fusion product platform. We believe that Fusion represents breakthrough technology on many, many fronts. This is a product that offers Medwave's sensor-based blood pressure solution, while also incorporating market leading Pulse Oximetry (SpO2) from Nellcor and thermometry from Kendall, both operating companies of Tyco Healthcare Group LP. Fusion will offer many unique and innovative features to the vital signs markets, including the Medwave Vasotrac® blood pressure measurement technology proven to be very effective on difficult-to-monitor patients. Fusion can be configured from a stand-alone blood pressure device into a complete vital signs monitor and is the first non-invasive blood pressure and vital signs monitor that is purely sensor-based. We are all very proud of the accomplishments of our recently introduced Primo(TM) spot blood pressure product, and we feel that with Fusion on the horizon, we will have the ability to offer our innovative, breakthrough solutions in a multitude of clinical environments."
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 else blood pressure monitoring takes place. Medwave has the required technology clearances to market its technology in the United States, Europe, and Asia. Medwave's technology is installed in over 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 Primo(TM) 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(TM), Primo(TM), and Fusion(TM) are trademarks of Medwave, Inc.
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