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UroNav is a stereotaxic medical device intended to assist the clinician with planning and guidance for clinical, interventional and/or diagnostic procedures for biopsy and/or soft tissue ablation. It provides 2D and 3D visualization of Ultrasound (U/S) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR). It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, grid plate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 2D/3D image registration. UroNav is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland. The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.

The system assists physicians in guiding interventional instruments to pre-defined targets, which may be identified pre-procedurally or intra-procedurally using imaging data or relative to a designated position on the patient. As an image fusion system, UroNav combines pre-procedural imaging, such as Magnetic Resonance Imaging (MRI), with real-time intra-procedural imaging from ultrasound (US) systems. This fusion capability enables precise localization of areas of interest detected in one imaging modality and maps them onto another. The system also facilitates spatial registration between two-dimensional (2D) and three-dimensional (3D) imaging datasets and between imaging data and physical patient space. The UroNav 4 System includes the following components: - **Electromagnetic Measurement System (EMMS):** Comprising a Field Generator, System Control Unit, and System Interface Unit(s) for electromagnetic tracking. - **System Unit:** Incorporating a central processing unit (CPU), monitor, medical-grade power supply, mobile cart, and UroNav software. - **Field Generator Stand:** Ensuring stability for electromagnetic tracking during procedures. - **Software Features:** Patient data management, multiplanar reconstruction, segmentation, image measurement tools, and 3D image registration capabilities. - **Compatible Devices:** Compatible with commercially available ultrasound machines, probes, needle guides, biopsy devices, and applicators. The system reconstructs 3D ultrasound images from live 2D video streams connected to ultrasound systems. Clinicians can select targets and navigate instruments with precision through its interactive interface, which features a keyboard, mouse, and visual display. The UroNav system supports diverse clinical environments, such as hospital operating rooms, outpatient surgery centers, ultrasound suites, and procedure rooms. The UroNav 4 design ensures compatibility with existing clinical workflows by utilizing commercially available ultrasound machines and accessories. Additional software functionalities include patient data management, multiplanar reconstruction of images, segmentation tools for enhanced visualization, image measurements, and 3D image registration. The UroNav 4 System is intended to aid physicians in performing minimally invasive diagnostic and therapeutic procedures by providing real-time image-guided navigation. It is not intended to replace physician judgment.