Home » FusionVu Application Cleared by FDA for Prostate Biopsies
FusionVu Application Cleared by FDA for Prostate Biopsies
Devices Submissions and Approvals
Exact Imaging, an ultrasound system developer, received 510(k) clearance for adding its Fusion Vu application to the ExactVu micro-ultrasound platform.
The application allows urologists to perform cognitive MRI transrectal ultrasound or micro-ultrasound/MR fusion on the ExactVu high resolution platform.
The new application provides 70-micron real-time resolution of the micro-ultrasound system for targeted prostate biopsies.