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

October 16, 2019 / Portfolio News

TORONTO, CANADA — Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announces it has received FDA 510(k) clearance for its Sterile Transperineal Needle Guide for use with 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.

Related Article: Exact Imaging Receives CE Mark Approval

“There is increasing movement towards transperineal-based prostate biopsies as an option to reduce the risk of infection. With FDA 510(k) clearance for our new Sterile Transperineal Needle Guide, the ExactVu micro-ultrasound system can now be used in all clinical settings for targeted prostate biopsies, including FusionVu™ and cognitive fusion biopsies.”

– Randy AuCoin, Exact Imaging’s President and CEO

ExactVu micro-ultrasound system, its FusionVu application along with the newly released Sterile Transperineal Needle Guide will be showcased live at the LUGPA 2019 Annual Meeting in Chicago, Illinois from November 7-9, 2019 and the 28th Annual Perspectives in Urology: Point Counterpoint in Scottsdale, Arizona from November 14-16, 2019.

“The ExactVu technology broadens my prostate biopsy options and can be performed in the clinic or in an outpatient surgery center. 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.”

– Neal D. Shore, MD, FACS, Medical Director for the Carolina Urologic Research Center and the National Urology Research Director for 21st Century Oncology

About Exact Imaging

Exact Imaging is the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging’s ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and is an extension of the current urological workflow. Using the Exact Imaging platform, urologists are able to visualize areas of interest in the prostate and specifically target biopsies at those areas. For those cases where MRI might assist, the FusionVu™ micro-US/MRI fusion application operates on the ExactVu micro-ultrasound platform and facilitates fast, simple MRI fusion-based targeting with the guidance of the micro-ultrasound system’s 70-micron real-time resolution. The ExactVu micro-ultrasound system including the FusionVu application has received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)), and Canada (Health Canada medical device license). 

For further information, please contact:

Randy AuCoin
President & CEO
Exact Imaging
T. +1.705.927.0512
E. raucoin@exactimaging.com

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