Exact Imaging, the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, 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, California.

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