Exact Imaging has secured CE mark approval for its ExactVu micro-ultrasound system for prostate imaging and biopsy guidance.
The imaging platform has unmatched real-time resolution (down to 70 microns).
The system’s high resolution will obtain from its operating frequency of 29MHz, while conventional ultrasound systems will have operating frequencies between 9MHz and 12 MHz.
The high resolution capability will enable urologist to visualize suspicious regions, in addition to carrying out systematic biopsies.
ExactVu system also allows to carry out biopsies targeted at suspicious regions in the prostate. The system is not yet received approval in the US and Canada
Exact Imaging said that it will shortly open new European headquarters in Belgium to expand its direct sales, clinical applications and technical support operations in the region.
Exact Imaging president and CEO Randy AuCoin said: “We are thrilled with the achievement of CE Mark approval for our ExactVu system, which is the culmination of many years of technical development.
“There is significant built-up demand for acquiring the ExactVu instrument and this approval will allow us to be able to commercialize our platform in Europe.
“With the ExactVu platform, urologists will have a new level of real-time resolution to facilitate actually targeting their prostate biopsies at suspicious regions.”
Exact Imaging is engaged in the development of high resolution micro-ultrasound systems for real-time imaging and biopsy guidance of the prostate cancer.
Image: Micrograph showing normal prostatic glands and glands of prostate cancer. Photo: courtesy of Nephron.