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Back To Vidyya Physiometrix Receives FDA Clearance For Patient State Analyzer

System Monitors Patient's Level Of Consciousness During General Anesthesia

Physiometrix, Inc. announced today that it has received 510(k) clearance from the U.S. FDA to market its PSA 4000 anesthesia monitoring system, designed to help clinicians assess and manage a patient's level of consciousness during surgery.

"FDA clearance is a significant achievement for Physiometrix," said John A. Williams, president and chief executive officer. "The speedy and positive response of the FDA is a clear indicator of the quality and breadth of our clinical data. Obtaining FDA clearance represents the critical final step in the commercial progression of our PSA 4000."

About the PSA

Each year, some 200,000 American patients wake up during their surgery in hospital operating rooms, and in certain cases complications arising from anesthesia can lead to death. Designed for use by anesthesiologists during surgery, the PSA is an early-warning device that enables the anesthesiologist to monitor and manage a patient's level of consciousness during an operation. The PSA has the potential to enhance patient care, improve recovery times and save lives in hospitals across the US and around the world.

In May, Physiometrix entered into a strategic partnership with Baxter for commercial distribution of the PSA 4000. As part of the agreement, Baxter will introduce the PSA 4000 to anesthesiologists through its full-time field sales organization, combining both the device and pharmaceutical groups.

"We are anxious to work with Baxter, our exclusive distribution partner, to launch the PSA 4000 in operating rooms across the U.S. and worldwide. Baxter has shown an enormous amount of confidence in the PSA 4000, which was validated by the FDA's ruling. Together with Baxter, we intend to make the PSA 4000 the standard of care in anesthesia monitoring."- John A. Williams, CEO.

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Editor: Susan K. Boyer, RN
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