FDA Clears Advanced UroNav System for Precision Focal Therapy in Prostate Cancer
Key Insights
The FDA has granted 510(k) clearance to an updated version of the Philips UroNav System (search), featuring advanced annotation workflow for enhanced precision in minimally invasive prostate cancer focal therapy procedures.
The platform integrates pre-procedural MRI imaging with real-time intra-procedural ultrasound to provide clinicians with comprehensive visualization of target areas during treatment.
The system works in tandem with DynaCAD Urology (search) to support focal therapy planning, delivery, and review, allowing urologists to edit prostate segmentation and add targets as needed.
The FDA has granted 510(k) clearance to an updated version of the Philips UroNav System (search), an advanced image-guided navigation platform designed to enhance the precision of minimally invasive therapy procedures in prostate cancer. The latest version includes an advanced annotation workflow specifically designed to deliver more precise care during focal therapy procedures.
Enhanced Imaging Integration for Targeted Treatment
The updated UroNav System (search) integrates pre-procedural imaging with real-time intra-procedural ultrasound to provide clinicians with a comprehensive and dynamic view of the target area. This magnetic resonance imaging (MRI)/ultrasound fusion platform combines diagnostic MR images with real-time ultrasound guidance to facilitate improved targeting of minimally invasive therapeutic procedures for prostate cancer.
"We're entering a new era of precision prostate cancer care. Philips' integrated focal therapy platform unifies imaging, biopsy pathology, treatment planning, and 3D imaging guidance with MR/US fusion, giving clinicians end-to-end efficiency and control," said Ardeshir R. Rastinehad, DO, vice chair of urology at Lenox Hill Hospital (search) and system director of prostate cancer at Northwell Health. "With fused imaging and real-time ablation guidance in one place, we can personalize therapy with greater accuracy and spare patients the unnecessary side effects of traditional treatments."
Workflow Integration and Clinical Applications
The new advanced annotation workflow on the UroNav System (search) is designed to work in tandem with DynaCAD Urology (search) to support focal therapy planning, delivery, and review. DynaCAD Urology can display prostate boundaries and targets defined by radiology, allowing urologists to edit prostate segmentation and add targets if needed. The resulting treatment plan can then be utilized by the Philips UroNav System for procedure guidance.
Interventional radiologists and other clinicians may combine UroNav's advanced annotation feature with the DynaCAD Urology (search) modality to enhance the planning and delivery of focal therapy for patients with prostate cancer. Beyond focal therapy applications, the UroNav System (search) can also be used for image guidance during prostate biopsies.
Technical Enhancements and System Integration
According to Royal Philips, the updated platform delivers enhanced compatibility with ultrasound devices and needle guides, upgraded privacy and security protections, and seamless integration with Philips DynaCAD systems for radiology and urology workflows.
"We're helping clinicians deliver more precise prostate cancer care by streamlining complex workflows and delivering the insights they need to support precise diagnosis and expand options for minimally invasive treatments," concluded Martijn Hartjes, Business Leader, Clinical Informatics at Philips. "Our goal is to equip clinicians with the clinical tools required so they can deliver better care for more patients."