Physiometrix Files 510(k) with FDA For Next Generation Monitor

Share Name	Share Symbol	Market	Type
Physiometrix (MM)	NASDAQ:PHYX	NASDAQ	Common Stock

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Physiometrix Files 510(k) with FDA For Next Generation Monitor

08/01/2004 1:00pm

PR Newswire (US)

Physiometrix (NASDAQ:PHYX)
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Physiometrix Files 510(k) with FDA For Next Generation Monitor NO. BILLERICA, Mass., Jan. 8 /PRNewswire-FirstCall/ -- Physiometrix, Inc. (NASDAQ-SCM: PHYX) announced today that it has submitted a 510(k) application to obtain clearance for commercial distribution of its PSA 5000 next generation monitor to the U.S. Food and Drug Administration (FDA). The PSA 5000 is a new state of the art monitor that is more powerful, cost effective and ergonomic than it's predecessor the PSA 4000. "The conclusion of this development effort represents a significant step forward for Physiometrix," said John A. Williams, president and chief executive officer. "We believe this next generation technology, with several new features, will further differentiate us from our competition. With clinical studies being readied for distribution and a new marketing and sales focus with our Partners at Baxter, we believe that we are well positioned for success and 2004 will be a strong year for our company." Designed for use by anesthesiologists, the PSA 4000 is a device that enables an anesthesiologist to monitor and manage a patient's level of consciousness under anesthesia in the operating room or intensive care unit. The PSA 4000 has the potential to enhance patient care and improve recovery times in hospitals across the U.S. and around the world. Physiometrix, Inc. designs, manufactures and markets noninvasive medical products -- based on novel gel materials, sophisticated signal-processing electronics technologies, and proprietary software -- for use in anesthesia- monitoring during surgical procedures. Safe Harbor Statement Statements in this press release regarding Physiometrix's growth and future business results of the Company are "forward-looking" statements as defined in the Private Securities Litigation Reform Act of 1995. Such statements are based upon management's current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors that could cause actual results to differ materially from any forward-looking statements made by the Company include, among others, revenue estimates, dependence on existing and future products, uncertainty of market acceptance, intense competition, partnership agreements, and government regulations, especially regulatory approvals. Other relevant risks are described in the Company's Form 10-K filed March 28, 2003 and Form 10Q dated November 14, 2003, with the SEC. CONTACT: Daniel W. Muehl, CFO Physiometrix Inc. 978-670-2422 DATASOURCE: Physiometrix, Inc. CONTACT: Daniel W. Muehl, CFO of Physiometrix Inc., +1-978-670-2422 Web site: http://physiometrix.com/

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