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FDA approves SonixGPS needle guidance technology for vascular access procedures

Tue, 06/26/2012 - 5:49am
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.

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