FDA clears image-guided navigation platform for focal therapy in prostate cancer

The FDA has granted 510(k) clearance to an updated version of the Philips UroNav System, an advanced image-guided navigation platform designed to enhance the precision of minimally invasive therapy procedures in prostate cancer.¹

The system integrates pre-procedural imaging with real-time intra-procedural ultrasound.

The latest version of the platform includes an advanced annotation workflow designed to help deliver more precise care during focal therapy procedures. To this end, the system is designed to integrate pre-procedural imaging with real-time intra-procedural ultrasound to provide clinicians with a comprehensive and dynamic view of the target area.

“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 and system director of prostate cancer at Northwell Health, in a news release.¹ “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.”

The new advanced annotation workflow on the UroNav System is designed to work in tandem with DynaCAD Urology to support focal therapy planning, delivery, and review. DynaCAD Urology can be used to display prostate boundaries and targets defined by radiology, allowing urologists to edit prostate segmentation and add targets if needed. The resulting plan can then be used by the Philips UroNav System.²

According to Royal Philips, “In addition to clinical functionality, Philips UroNav 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.”

“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, in the news release from the company.¹ “Our goal is to equip clinicians with the clinical tools required so they can deliver better care for more patients.”

The UroNav System can also be used for image guidance during prostate biopsies.³

REFERENCES

1. Philips advances minimally invasive therapy procedures in prostate cancer care with FDA 510(k) clearance for image-guided navigation technology. News release. Royal Philips. July 23, 2025. Accessed July 23, 2025. https://www.philips.com/a-w/about/news/archive/standard/news/press/2025/philips-advances-minimally-invasive-therapy-procedures-in-prostate-cancer-care-with-fda-510-k-clearance-for-image-guided-navigation-technology.html

2. Prostate Cancer Diagnosis: connecting radiology and urology workflows for better care. News release. Philips. May 23, 2025. Accessed July 23, 2025. https://www.philips.com/a-w/about/news/archive/standard/news/articles/2025/prostate-cancer-diagnosis-connecting-radiology-and-urology-workflows-for-better-care.html

3. UroNav. Philips. Accessed July 23, 2025. https://www.usa.philips.com/healthcare/product/HC784026/uronav-mrultrasound-guided-fusion-biopsy-system