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The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland, and to be used by physicians for enhanced visualization of two-dimensional (2D) transrectal ultrasound TRUS images of the prostate in clinic and hospital settings. It allows the user to segment medical images and it performs three-dimensional (3D) reconstruction of digitized TRUS video images to form a 3D TRUS volume. The SmartTarget software provides 2D and 3D image visualization features, including the ability to review images, generate multi-planar views, annotate images, and identify and record the locations of instruments inserted during the procedure. The device is intended to be used in diagnostic and treatment procedures in a clinical setting in which a needle or other instrument is inserted into the prostate through the perineum or urethra, or instruments that are positiond externally to the prostate so that treatment can be delivered to prostate insue, or diagnostic information obtained from prostate tissue. Example procedures include, but are not limited to: needle biopsy in which tissue samples are removed from the prostate; in situ diagnostic techniques, such as those based on optical sensing; thermal tissue ablation using radiofrequency, microwave, laser, cryotherapy, or high-intensity focused ultrasound; photodynamic therapy; irreversible electroporation; radioactive source implantation (brachy-injected drug therapies

The SmartTarget software is designed for the fusion/registration of transrectal ultrasound (TRUS) images of the prostate with three-dimensional (3D) images, such as a magnetic resonance image (MRI) or x-ray computed tomography (CT) image etcetera, during procedures for which TRUS is used to provide real-time imaging of the prostate, nearby anatomical structures, and instruments inserted into the prostate to guide instrument placement. The software supports the following tasks: computer-assisted surgical planning, allowing target regions to be defined within the prostate in a diagnostic/planning image and TRUS images; reconstruction of 3D TRUS images from multiple US video frames, captured at pre-set intervals as the TRUS probe is translated or rotated; and image fusion/registration wherein the spatial relationship between prostate in the diagnostic/planning image and TRUS images is calculated. The system software reproduces and supplements the visual information provided by real-time TRUS images, and superimposes a graphical representation of one or more target regions on to the reproduced TRUS images. The target region(s) may represent a tumor, another tissue structure visible in the diagnostic/planning image, or a location of clinical relevance (such as a region from which tissue samples are to be removed).Displayed target regions provide additional information to the TRUS image, enabling the operating clinician to direct instruments to these regions.