Exact Imaging’s Abdominal Imaging Release Receives CE Mark Approval

Jennifer Schram Exact Imaging, Portfolio News, Press Release

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SOURCE: Exact Imaging
New EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities enable the ExactVu™ micro-ultrasound system to provide a complete men’s health urological imaging solution

TORONTO, CANADA — (May 7, 2019) Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced it has received CE Mark Approval for its Abdominal Imaging Release including its new EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities. Operating on the ExactVu™ micro-ultrasound system, the EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities allow urologists to perform complete urological ultrasound assessments including kidney examinations and biopsies, male pelvic and bladder examinations.  The ExactVu™ system, which is the only urological ultrasound platform to operate both conventional as well as high resolution (29 MHz) transducers, now provides the ultimate “total men’s health” imaging solution. It can provide a complete abdominal urological ultrasound assessment of a patient as well as providing the fastest, simplest real-time targeting of prostate biopsies, while providing the highest real-time resolution for guidance for those prostate biopsies.

“We are thrilled to have received our CE mark approval for our Abdominal Imaging Release.  The demand is significant for a urological imaging platform that merges the 70-micron resolution of the ExactVu™ micro-ultrasound system for real-time targeted prostate biopsies with the ability to provide a complete urological ultrasound assessment of a patient,” said Randy AuCoin, Exact Imaging’s President and CEO. “The goal is to provide urologists with the most flexible, innovative imaging solution to help urologists better diagnose urological disease. We believe this release helps to further establish the ExactVu™ platform as a most useful, cost-effective men’s health imaging solution.”

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 have received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license).  Regulatory approval for the EV5C Abdominal transducer and Color Flow and Power Doppler capabilities in the United States and Canada is pending.

Media Relations:

Rob Sandler                                                    
SVP, Marketing                                              
Exact Imaging                                                
T.  +1.416.274.8166                                          
E.  rsandler@exactimaging.com                   
W. www.exactimaging.com    

Related Article: Exact Imaging Wins 2019 “Life Science Company of the Year” from Life Science Ontario (LSO)