FDA Clears Philips' Upgraded UroNav System for Enhanced Prostate Cancer Diagnosis

The U.S. FDA has granted 510(k) clearance for Philips’ latest UroNav image-guided navigation system, marking a significant step forward in precision prostate cancer care. The advanced platform integrates pre-procedural MRI with real-time ultrasound for improved biopsy accuracy, enabling clinicians to conduct fusion-guided biopsies via either transrectal or transperineal routes.

Designed to streamline complex workflows, UroNav now features enhanced compatibility with various ultrasound systems, needle guides, and the DynaCAD Urology platform. The new version supports 3D biopsy review, image/video capture, and annotation tools for improved focal therapy guidance.

It also incorporates upgraded data privacy and security measures, aligning with Philips’ broader push for minimally invasive, image-guided therapies. The platform supports a seamless integration of biopsy, imaging, digital pathology, and therapy planning, helping clinicians deliver more precise, personalized care.

This clearance follows the FDA’s earlier approval of Philips’ SmartSpeed Precise, a deep learning reconstruction tool.

27-07-2025