News | Prostate Cancer | December 09, 2016

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

Exact Imaging, a 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," said 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 percent 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.

For more information: www.exactimaging.com

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Credit: Courtesy of A. Baranski, M. Schäfer, U. Bauder-Wüst, M. Roscher, J. Schmidt, E. Stenau, L. Maier-Hein, M. Eder, K. Kopka, German Cancer Research Center, Heidelberg, Germany; T. Simpfendörfer, B. Hadaschik, U. Haberkorn, Heidelberg University Hospital, Heidelberg, Germany; PET-image: Afshar-Oromieh et al., EJNMMI 2013; 40(4); STED-image: J. Matthias, German Cancer Research Center.

This study was supported by the VIP+ fund, Federal Ministry of Education & Research (BMBF), Germany.

Scientific Paper 531: “Preclinical evaluation of dual-labeled PSMA-inhibitors for the diagnosis and therapy of prostate cancer.” A. Baranski, M. Schäfer, U. Bauder-Wüst, M. Roscher, J. Schmidt, E. Stenau, L. Maier-Hein, M. Eder, K. Kopka, German Cancer Research Center (DKFZ), Heidelberg, Germany; T. Simpfendörfer, B.  Hadaschik, U. Haberkorn, University Hospital, Heidelberg, Germany. Presented at SNMMI’s 64th Annual Meeting, June 10-14, 2017, Denver, Colo.

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