UroNav 4 is a medical image processing and navigation system that helps clinicians plan and guide biopsy and soft tissue ablation procedures, especially for the prostate gland. It fuses and registers 2D and 3D ultrasound images with other imaging modalities like MRI to provide real-time image guidance using electromagnetic tracking. This enhances precision in navigating interventional instruments, improving clinical outcomes in minimally invasive procedures.
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.
UroNav 4 combines pre-procedural MRI with real-time ultrasound via image fusion and spatial registration between 2D and 3D images. It uses electromagnetic tracking, advanced image segmentation, multiplanar reconstruction, and 3D visualization to assist navigation of interventional instruments. The system integrates commercially available ultrasound machines and provides a software interface with various image processing tools.
Comprehensive non-clinical testing including software regression testing, usability and human factors validation, safety testing for data encryption and access control, system compatibility, electromagnetic tracking accuracy, advanced annotation workflow validation, kiosk mode validation, and privacy/security compliance was conducted. The system met all acceptance criteria and showed no new safety or effectiveness concerns compared to predicate devices.
No predicate devices specified
Submission
3/14/2025
FDA Approval
6/5/2025
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