Exact Imaging Receives CE Mark of Approval

September 10, 2019 / Portfolio News
Exact Imaging Receives CE Mark of Approval for Transperineal Needle

TORONTO, Sept. 10, 2019 /PRNewswire/ – Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, has received CE Mark approval 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 the guidance of prostate biopsies and with the growth of demand for the system in European markets and facilities that favor transperineal approaches for prostate biopsies, it is now able to be used in those clinical settings.

“The ability to perform targeted transperineal biopsies guided by ExactVu 29 MHz micro-ultrasound represents a real breakthrough by virtue of being able to image the target volume in real-time in the office.”

– Mark Emberton, Professor of Interventional Oncology, Division of Surgery and Interventional Science, University College London (UCL) and Clinical Director, Clinical Effectiveness Unit, Royal College of Surgeons of England

Related Article: Exact Imaging’s Abdominal Imaging Release Receives CE Mark Approval

The ExactVu™ micro-ultrasound system, its FusionVu™ application and the newly released Sterile Transperineal Needle Guide will be showcased live at the forthcoming major European urology meetings, DGU 2019 in Hamburg, SIU 2019 Congress in Athens, ESUI19 / EMUC19 in Vienna, and AFU 2019 in Paris.

“In some markets, there is increasing movement towards transperineal-based biopsies, with the aim of reducing rates of infection. With the CE Mark 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, President & CEO, Exact Imaging

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). 

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