Exact Imaging has won Health Canada approval for its FusionVu application that is used for micro-ultrasound/MRI fusion with the ExactVu high resolution micro-ultrasound system.
“We are excited to have received regulatory approval from Health Canada allowing our FusionVu application, a feature of our ExactVu micro-ultrasound system, to be commercially available in Canada,” Randy AuCoin, president and CEO of Exact Imaging, said. “The ExactVu micro-ultrasound system provides the highest real-time resolution for targeted prostate biopsies. Urologists who appreciate the benefit of MRI for select clinical cases, such as patients with repeat negative biopsies but with increasing risk indications, can now have the best of both worlds. The can leverage FusionVu to align the patient’s MRI with the live micro-ultrasound image to either perform Cognitive Assist or micro-ultrasound/MRI fusion-guided biopsies, all with the benefit of the 70-micro resolution of micro-ultrasound.”
The new approval allows Canadian customers to use the FusionVu application. It has already received CE Mark approval for commercial access in Europe and FDA 510(k) clearance for U.S. commercial access.