Philips UroNav System for Prostate Cancer Treatment Cleared by FDA

August 5, 2025—Royal Philips recently announced FDA 510(k) clearance of the latest version of the company’s UroNav system for image-guided navigation in prostate cancer care treatment. The system includes a new advanced annotation workflow that supports clinicians during focal therapy procedures to help deliver precise minimally invasive care, stated the company.

According to Philips, UroNav is an image fusion system that integrates preprocedural imaging, such as magnetic resonance imaging, with real-time intraprocedural imaging from ultrasound systems. This combination is intended to enhance the precision and accuracy of therapeutic procedures, providing clinicians with a comprehensive and dynamic view of the targeted area.

The new annotation workflow works in tandem with the company’s DynaCAD Urology to support focal therapy planning, deliver, and review; to reduce complexity; and to enable a broader group of clinicians to offer minimally invasive options, noted Philips.



Ardeshir Rastinehad, DO, who is Vice Chair of Urology at Lenox Hill Hospital and System Director of Prostate Cancer at Northwell Health in New York, New York, discussed the development in Philips’ press release.

“We’re entering a new era of precision prostate cancer care,” commented Dr. Rastinehad. “Philips’ integrated focal therapy platform unifies imaging, biopsy pathology, treatment planning, and three-dimensional imaging guidance with magnetic resonance ultrasound fusion, giving clinicians end-to-end efficiency and control. 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.”