Philips, B. Braun receive FDA clearance for Onvision Needle Tip Tracking technology for regional anesthesia

August 26, 2020 – Royal Philips and B. Braun Medical Inc. (Bethlehem, PA) announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Onvision, a breakthrough ultrasound guidance solution for real-time needle tip tracking.

Available exclusively on the latest version of the B. Braun and Philips Xperius ultrasound system together with the dedicated Stimuplex Onvision needle, Onvision gives anesthesiologists the confidence to accurately position the needle tip inside the body for Peripheral Nerve Blocks (PNBs).

The company says that the Onvision accurately indicates, in real time, where the needle tip is inside the body, both in and out of the ultrasound viewing plane. This can help users align the needle with the probe in a user-friendly interface that that the companies say can lead to a reduction in procedural time.

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, according to the companies.

The Onvision solution is also CE marked and available for sale across the EU and in Chile. It is expected to be available in the U.S. in Q4 2020.

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