Exact Imaging Receives FDA 510(k) Clearance for Sterile Transperineal Needle Guide

October 24, 2019 — Exact Imaging received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sterile Transperineal Needle Guide for use with the Exact Imaging EV29L transducer. Operating on the ExactVu micro-ultrasound system, the Sterile Transperineal Needle Guide now allows urologists to perform targeted prostate biopsies, leveraging the near microscopic resolution of the micro-ultrasound for transperineal-based biopsies. The ExactVu system provides the highest real-time resolution for guidance of prostate biopsies and may now be used in procedures that use transperineal approaches for prostate biopsies.

Exact Imaging President and CEO Randy AuCoin said the new needle guide reflects a trend in the industry toward transperineal-based prostate biopsies as an option to reduce the risk of infection. The ExactVu miro-ultrasound system can now be used in all clinical settings for targeted prostate biopsies, including FusionVu and cognitive fusion biopsies. 

“The ExactVu technology broadens my prostate biopsy options and can be performed in the clinic or in an outpatient surgery center,” said Neal D. Shore, M.D., FACS, medical director for the Carolina Urologic Research Center and the national urology research director for 21st Century Oncology. “As transperineal biopsy strategies evolve, potentially for enhanced tissue procurement, and therefore, enhanced histopathologic evaluation as well as the likelihood for decreased infectious complication risk, performing targeted transperineal biopsies using the ExactVu 29 MHz micro-ultrasound system optimizes the performance of prostate biopsy.”

ExactVu micro-ultrasound system, its FusionVu application along with the newly released Sterile Transperineal Needle Guide, will be showcased live at the Large Urology Group Practice Association (LUGPA) 2019 annual meeting, Nov. 7-9 in Chicago, 2019 and the 28th Annual Perspectives in Urology: Point Counterpoint, Nov. 14-16 in Scottsdale, Ariz.

For more information: www.exactimaging.com