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
"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
"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.
Web site: www.physiometrix.com