Philips UroNav Receives FDA Clearance for Advanced Annotation Workflow

Philips has received FDA 510(k) clearance for its latest UroNav version, a system that enables image-guided navigation for prostate cancer care. The new version includes an advanced annotation workflow that supports clinicians during focal therapy procedures, helping deliver more precise and minimally invasive care.

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, has received FDA 510(k) clearance for its latest UroNav version, marking a significant advancement in image-guided navigation for prostate cancer care. The new system includes an advanced annotation workflow that supports clinicians during focal therapy procedures, enabling more precise and minimally invasive care.

The UroNav system integrates pre-procedural Magnetic Resonance Imaging (MRI) with real-time intra-procedural ultrasound (US) imaging, providing a comprehensive and dynamic view of the targeted area. This innovative combination enhances the precision and accuracy of therapeutic procedures, offering clinicians a more informed treatment selection and better patient care.

Dr. Ardeshir Rastinehad, Vice Chair of Urology at Lenox Hill Hospital and System Director of Prostate Cancer at Northwell Health, stated, "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."

The new advanced annotation workflow works in tandem with DynaCAD Urology to support focal therapy planning, delivery, and review, reducing complexity and enabling a broader group of clinicians to offer minimally invasive options. This innovation addresses the growing need for precision in prostate cancer treatment, which remains the most commonly diagnosed solid tumor among men in the United States, with over 313,000 new cases annually [1].

Clinical data shows a 30% improvement in high-risk prostate cancer diagnosis using fusion biopsy compared to standard biopsy methods [2]. The enhanced imaging capabilities and advanced annotation workflow in the Philips UroNav system support clinicians in delivering more precise, minimally invasive care, reducing the risk of overtreatment and associated side effects.

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. Philips' comprehensive urology portfolio integrates imaging, biopsy, therapy guidance, and digital pathology to support precision diagnosis and treatment—enabling clinicians to tailor care with greater efficiency and confidence.

From a financial perspective, the FDA clearance of the Philips UroNav system could potentially boost Koninklijke Philips NV's market position in the health technology sector. The innovation aligns with the company's strategy to enhance its portfolio in diagnostic imaging and image-guided therapy, potentially driving revenue growth. However, the separate sale of the advanced annotation option may impact the overall adoption rate among healthcare providers.

The introduction of the Philips UroNav system addresses a critical need in prostate cancer care, offering a more targeted and precise approach to treatment. This innovation is likely to appeal to healthcare providers seeking to improve patient outcomes and reduce the side effects associated with traditional treatments.

References:
[1] Key Statistics for Prostate Cancer. American Cancer Society. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html
[2] Siddiqui MM, et al. Comparison of MR/ultrasound fusion–guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015;313(4):390-397.