Ultrasonix Medical Corporation has received approval from
the US Food and Drug Administration for its SonixGPS technology for Vascular
Access procedures.
First approved for use in Canada, the SonixGPS
technology has been used in hospitals in British Columbia and Ontario since
October 2011. Clinical studies have proven the accuracy and clinical benefits
of using the new technology for guidance procedures such as nerve blocks for
regional anesthesia and pain management and vascular access procedures. The
guidance technology is also useful for difficult biopsies, aspirations and
placement of therapeutic agents.
“My experience using GPS in a teaching environment has shown
that both junior and senior clinicians are quite taken by the power of the GPS
to convey the sense of needle localization on screen, both before you enter the
tissue and once you achieve the exact plane at which you want to pass a guide
wire for central venous cannulation,” said Dr. Brian Pollard.
SonixGPS helps clearly predict and see the needle’s
trajectory during invasive procedures. Unlike other guidance technologies, SonixGPS
enables clinicians to position the transducer in the ideal location to see the
target and to select a needle direction and angle that is safest and most
comfortable for the patient. It always shows the predicted trajectory and true
path of the needle in real time. Needle adjustments are reflected instantly on
the display.
“Our SonixGPS
technology exemplifies our company’s focus on innovation, guidance and
simplicity. We are delighted to have regulatory approvals in key global areas,”
said Laurent Pelissier, Founder and Chief Executive Officer of Ultrasonix. “We
believe our guidance technology can improve patient safety and save physicians
valuable time. We look forward to expanding its footprint.”
SonixGPS has received CE Mark for both nerve blocks and
vascular access. SonixGPS for nerve block procedures is pending FDA 510(k). The
SonixGPS option is available on the SonixTouch, SonixTablet and SonixMDP
ultrasound systems.
About Ultrasonix
Ultrasonix develops and manufactures diagnostic ultrasound imaging systems with
customizable touch screens to simplify workflows. The company’s systems are
built on an open software platform that enables remote service and easy updates
to keep current with advancements in imaging technology. Founded in 2000,
Ultrasonix is a privately-held company headquartered in Richmond, British
Columbia, Canada. www.ultrasonix.com/gps.