Exact Imaging obtains CE Mark for EV5C abdominal transducer imaging software

Abdominal imaging software for Exact Imaging’s EV5C Abdominal Transducer and Color Flow and Power Doppler software has received CE Mark approval. The software, which operates on the ExactVu™ micro-ultrasound system, allows urologists to perform complete urological ultrasound assessments including kidney examinations and biopsies, male pelvic, and bladder examinations, according to the Toronto, Ontario-headquartered company.

The ExactVu system operates on both conventional as well as high resolution 29 MHz transducers. It can provide a complete abdominal urological ultrasound assessment of a patient as well as providing fast, simple real-time targeting of prostate biopsies. Urologists are able to visualize areas of interest in the prostate and specifically target biopsies at those areas using the Exact Imaging platform.

The ExactVu micro-ultrasound system, including a FusionVu™ micro-ultrasound/magnetic resonance imaging fusion application for MRI fusion-based targeting with the guidance of the micro-ultrasound system’s 70-micron real-time resolution, has received regulatory approval in the European Union, in the United States, and in Canada.

Exact Imaging said that regulatory approval for the EV5C Abdominal Transducer and Color Flow and Power Doppler software is pending with Health Canada and the U.S. Food and Drug Administration.