Philips Gains FDA Clearance for Next-Gen UroNav, Enhancing Precision in Prostate Cancer Therapy

Royal Philips received FDA 510(k) clearance for its updated UroNav image-guided navigation system. The system introduces advanced annotation capabilities and an optimized workflow designed to support focal therapy procedures for prostate cancer. This enables clinicians to deliver more targeted, less invasive care.

Prostate cancer remains the most commonly diagnosed solid tumor among men in the U.S., so precision-focused approaches are becoming increasingly important. The new UroNav system integrates pre-procedural MRI with real-time ultrasound imaging to improve biopsy and therapy accuracy. It also seamlessly integrates with Philips’ DynaCAD Urology platform to aid in focal therapy planning, delivery, and review.

UroNav streamlines complex imaging and therapeutic workflows, supporting a 30% improvement in diagnosing high-risk prostate cancers using fusion biopsy. The upgrade also enhances device compatibility, data security, and integration with digital pathology solutions, helping clinicians make more informed decisions and reduce unnecessary side effects for patients.