COPENHAGEN, DENMARK and TORONTO, CANADA -- (March 16, 2018) Exact Imaging (www.exactimaging.com), 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 FusionVu™ Micro-Ultrasound/MRI Fusion application. Operating on the ExactVu micro-ultrasound system, FusionVu now allows urologists to perform either cognitive fusion via Cognitive Assist™ or micro-ultrasound/MR fusion on the high-resolution platform. With either approach, FusionVu enables the fastest, simplest real-time targeting of prostate biopsies - - and provides the highest real-time resolution for guidance for those prostate biopsies.
“We are thrilled to have received our CE mark approval for our FusionVu application, as the demand is significant for a platform that merges the 70-micron resolution of the ExactVu micro-ultrasound system with the ability to supplement decision-making with either MR images or by using MRI reports for cognitive fusion,” said Randy AuCoin, Exact Imaging’s President and CEO. “The goal is to provide urologists with the best information in real time so that they can visualize suspicious regions and optimally target their prostate biopsies, and do so in the fastest, simplest and most cost-effective manner.”
The ExactVu high resolution micro-ultrasound system and the FusionVu application including Cognitive Assist is being demonstrated live this coming week at the Exact Imaging Booth #D29 at the Annual Meeting of the EAU (European Association of Urology) 2018 in Copenhagen, Denmark.
About Exact Imaging
Exact Imaging (www.exactimaging.com) 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 being 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, aided by the PRI-MUS™ (prostate risk identification using micro-ultrasound) evidence-based micro-ultrasound protocol. For the minority of cases where MRI might assist (i.e., prior negative biopsies), FusionVu™ is the micro-US/MRI fusion application operating on the ExactVu micro-ultrasound platform enabling cognitive fusion called Cognitive Assist™ or fusion with MR images. The ExactVu micro-ultrasound system has received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license).
