Philips Receives FDA 510(k) Clearance for Next-Gen UroNav Image-Guided Navigation System

Philips has announced that it has received FDA 510(k) clearance for its latest UroNav image-guided navigation system, marking a significant advancement in prostate cancer care.

The newly enhanced UroNav system features an advanced annotation workflow designed to support clinicians during focal therapy procedures, helping to deliver more precise and minimally invasive care. The platform integrates pre-procedural imaging (such as MRI) with real-time ultrasound, enabling image fusion that provides a comprehensive view of the targeted treatment area.

According to Philips, this targeted imaging approach enhances treatment decision-making and enables more personalized and effective care strategies. The system’s new workflow also works seamlessly with DynaCAD Urology to support the planning, delivery, and review of focal therapies.

Beyond its clinical features, UroNav offers enhanced compatibility with various ultrasound systems and needle guides, improved data privacy and security, and full integration with Philips’ DynaCAD platforms for both radiology and urology applications.

“Our aim is to streamline complex workflows and equip clinicians with the tools they need to offer more precise and minimally invasive prostate cancer treatments,” said Martijn Hartjes, Business Leader, Clinical Informatics at Philips.