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. Earlier this month the device gained CE mark clearance and now FDA too has given the technology the nod.
Clinical studies suggest greater accuracy provides clinical benefits when using the new technology for guidance procedures such as nerve blocks for regional anaesthesia, pain management and vascular access procedures. Guidance technology is also potentially useful for difficult biopsies, aspirations and placement of therapeutic agents.
According to Ultrasonix, its 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.
“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.
“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.”
Comments on regulatory status
SonixGPS has received CE Mark for both nerve blocks and vascular access. SonixGPS for nerve block procedures is pending FDA 510(k).