Imaging company Exact Imaging revealed on Wednesday the receipt of Health Canada's approval for its FusionVu application for micro-ultrasound/MRI fusion using the ExactVu high resolution micro-ultrasound system for the highest real-time resolution for targeted prostate imaging and biopsy.
This approval allows the company's Canadian customers to use the FusionVu application.
In addition, the company's ExactVu micro-ultrasound system and FusionVu have received regulatory approval in the EU (CE Mark), the US(FDA 510(k)) and Canada (Health Canada medical device license).
The company said the 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 is an extension of the current urological workflow. The urologists are able to visualise areas of interest in the prostate and specifically target biopsies at those areas using the Exact Imaging platform.
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