Philips and B. Braun receive FDA clearance for needle tip tracking for regional anesthesia
Royal Philips and B. Braun Medical Inc. announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Onvision, an ultrasound guidance solution for real-time needle tip tracking.
Accurate needle placement is critical to the success of regional anesthesia procedures, such as Peripheral Nerve Blocks (PNBs). While real-time ultrasound imaging has proved to be a valuable tool for needle guidance, failure to optimally visualize the needle tip remains a challenge, with 10-15 percent of all PNBs ineffective after a single-injection technique.
Together, B. Braun’s Stimuplex Onvision needles and Philips’ Onvision needle tip tracking technology indicate the position of the needle tip in relation to the ultrasound viewing plane to an accuracy of 3mm. A sensitive micro-sensor placed on the needle, combined with advanced signal processing and visualization techniques on the Xperius system, indicate the real-time location of the needle tip in relation to the 2D ultrasound viewing plane. The solution provides greater flexibility in needle trajectory and can reduce procedure times.
