Focalyx Fusion - The Focalyx Fusion system is designed for the fusion/registration of MRI and transrectal ultrasound (TRUS) images of the prostate during a transperineal biopsy or therapy procedure. The software supports computer-assisted surgical planning and provides a tool for real-time surgical guidance by reproducing and supplementing the visual information provided by real-time ultrasound imaging. The intended use of the system is to superimpose a graphical representation of one or more surgical targets on to real-time US images of the prostate to aid targeted needle guidance in the diagnosis or treatment of prostate disease. The system is to be used by qualified physicians who are familiar with the safe operation of transrectal ultrasound and positioning devices during medical procedures involving the prostate. There are no known contraindications for the use of the device.
2026-01-02