Exact Imaging Receives FDA 510(k) Clearance for Its ExactVu™ Micro-Ultrasound System
New Disruptive Prostate Micro-Imaging and Biopsy System Approved for Commercial Release in the United States
TORONTO, Dec. 8, 2016 /PRNewswire/ - Exact Imaging (www.exactimaging.com), the world's leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, announced it has received FDA 510(k) Clearance for its ExactVu™ micro-ultrasound system.
"This has been a great few weeks with the receipt of our 510(k) clearance and the announcement of our CE approval just two weeks ago," says Randy AuCoin, Exact Imaging's President and CEO. "These important regulatory approvals will allow our commercial team to start fulfilling the pent-up demand for the ExactVu micro-ultrasound system. The era of blind, unguided biopsies is coming to an end and urologists are searching for new tools that leverage break-through technologies, familiar workflows and allow them to benefit from improved imaging resolution to target their prostate biopsies. Our platform is such a solution – it images in real-time, it is located in the urologist's office, and it is ultrasound-based. Most important, it allows for the guidance of both systematic and targeted biopsies due to its exquisite resolution."
With resolution down to 70 microns - - or 0.07 of a millimeter, the ExactVu high resolution system provides a 300% improvement in imaging resolution compared to the traditional standard-of-care urological ultrasound systems. Urologists now have a tool, designed around their workflow, to facilitate the detailed interrogation and visualization of suspicious regions and perform targeted prostate biopsies.
The ExactVu micro-ultrasound recently received CE marking enabling sales of the system in Europe. Exact Imaging's European commercial operations are being set-up in its new European headquarters in Belgium. With this 510(k) clearance, North American sales, clinical applications and technical support teams are being expanded to support the anticipated growth in US customers.
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 will now be able to visualize areas of interest in the prostate and specifically target biopsies at those areas in addition to performing systematic biopsy protocols. The ExactVu™ micro-ultrasound system is available for sale in the European Union (CE Mark) and the United States (FDA 510(k) clearance). The product is not yet commercially available in Canada. The company was founded in 2013 by Sam Ifergan (iGan Partners) and Randy AuCoin to develop and commercialize this novel high-resolution technology in order to disrupt the market and enable new levels of clinical imaging.
SOURCE Exact Imaging
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