Micro-ultrasound developer Exact Imaging said today it won CE Mark approval in the European Union for its Fusion Vu application designed for micro-ultrasound/MRI fusion-based targeted prostate biopsies.
The newly cleared application allows urologists to perform either cognitive fusion via Cognitivie Assist or micro-ultrasound/MR fusion on a high resolution platform, which the company said provides the “highest real-time resolution for guidance” for prostate biopsies.
“We are thrilled to have received our CE mark approval for our FusionVu application, as the demand is significant for a platform that merges the 70-micron resolution of the ExactVu micro-ultrasound system with the ability to supplement decision-making with either MR images or by using MRI reports for cognitive fusion. The goal is to provide urologists with the best information in real time so that they can visualize suspicious regions and optimally target their prostate biopsies, and do so in the fastest, simplest and most cost-effective manner,” Exact Imaging prez & CEO Randy AuCoin said in a prepared statement.
Last January, Exact Imaging said it raised $16.3 million (CDN $21.5 million) in a Series C funding round, with funds slated to support the commercialization of its ExactVu micro-ultrasound system.