Medical device company Exact Imaging has secured Health Canada's approval and the corresponding medical device license for its ExactVu high-resolution micro-ultrasound system.
The approval allows the firm to commercialise the system in Canada for prostate imaging and biopsy.
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The ExactVu micro-ultrasound system operates at 29MHz and provides high-resolution with ease of use, affordability and an extension to the existing urological workflow.
This platform enables urologists to visualise areas of interest in the prostate and specifically target biopsies at those areas in addition to performing systematic biopsy protocols.
Exact Imaging president and chief executive officer Randy AuCoin said: "We are very pleased to received our license and regulatory approval from Health Canada allowing our ExactVu micro-ultrasound system to be commercially available in Canada.
"We are especially excited to also announce our first Canadian sale to Dr Gregory Czarnota and Sunnybrook Health Sciences Centre and Sunnybrook Research Institute in Toronto, ON.
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By GlobalData"Dr Czarnota's important clinical research in apoptosis is trying to better understand the molecular mechanisms by which diseased cells die and therefore, how therapy can be most effectively applied."
According to Dr Czarnota, the high resolution imaging generates rich radio frequency data that can be evaluated and correlated with pathology, to apply against models for better understanding of apoptosis and response of cancerous cells to therapy.
The ExactVu micro-ultrasound system has also received CE mark approval in the European Union, and FDA 510(k) in the US.
