Philips Receives FDA Clearance for Ultrasound-Guided Needle Tracking

Royal Philips announced Tuesday it has received 510(k) clearance from the U.S. Food & Drug Administration for its Onvision system, an ultrasound solution for real-time needle-tip tracking during peripheral nerve blocks.

Ultrasound-guided imaging has improved the functionality and outcomes of regional anesthesia, but between 10 percent and 15 percent of all peripheral nerve blocks are still ineffective due to inaccurate needle placement. Onvision, available exclusively on the latest version of the B. Braun and Philips Xperius ultrasound system, is designed to reduce procedure time and help anesthesiologists more accurately position the needle tip by helping the provider align the needle with the probe in a user-friendly interface, company officials said.

“The increased confidence and predictability offered by the Xperius Ultrasound System and Onvision Needle Tip Tracking is empowering more anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia,” said Tobin Taylor-Bhatia, head of innovation for image guided therapy at Philips.

According to a company statement, this system can indicate the position of the needle tip in relation to the ultrasound viewing plan to within 3mm. Together, a micro-sensor on the needle and the signal processing and visualization techniques on the Xperius system can reveal the real-time location of the needle tip in relation to the 2D ultrasound viewing plane.

In addition, company officials said, the system maintains its accuracy even when the needle bends, and circles automatically appear when the needle tip sensor enters the imaging plane, bolstering confidence in both in- and out-of-plane blocks.