Devices Urology Oncology FDA

 News Release - May 3, 2018

Exact Imaging Receives FDA 510(k) Clearance for Adding the FusionVu Application to the ExactVu(TM) Micro-Ultrasound Platform

New state-of-the-art FusionVu application leverages 70-micron real-time resolution of the ExactVu™ micro-ultrasound system for targeted prostate biopsies

TORONTO, May 3, 2018 -- (Healthcare Sales & Marketing Network) - 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 FDA 510(k) Clearance for its FusionVu™ application on the ExactVu micro-ultrasound system. FusionVu allows urologists to perform either cognitive fusion via Cognitive Assist™ or micro-ultrasound/MR fusion on the ExactVu 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.

"Our 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. We are excited to have received FDA 510(k) clearance, as well as our CE mark approval for our FusionVu application," said Randy AuCoin, Exact Imaging's President and CEO. "Our growing global customer base will now have an even more comprehensive suite of applications by which to leverage the 70-micron resolution of the ExactVu platform to visualize the prostate, differentiate suspicious tissue and to guide targeted prostate biopsies in the fastest, simplest and most cost-effective manner."

The ExactVu high resolution micro-ultrasound system and the FusionVu application including Cognitive Assist are being demonstrated live from May 18 – 21, 2018 at the Exact Imaging Booth #5258 at the 2018 AUA (American Urological Association) Annual Meeting in San Francisco, CA.

FusionVu™ recently received CE marking enabling sales of the micro-ultrasound/MRI fusion application in Europe.

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. 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 (using Cognitive Assist™) and MRI fusion guided by real-time micro-ultrasound resolution. 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).

Source: Exact Imaging

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