Philips advances minimally invasive therapy procedures in prostate cancer care with FDA 510(k) clearance for image-guided navigation technology

Rhea-AI Summary

Philips (NYSE: PHG) has received FDA 510(k) clearance for its latest UroNav version, advancing image-guided navigation technology for prostate cancer care. The system features a new advanced annotation workflow that enhances focal therapy procedures through improved precision in minimally invasive care.

The technology combines pre-procedural MRI imaging with real-time ultrasound for enhanced therapeutic precision. Clinical data shows a 30% improvement in high-risk prostate cancer diagnosis using fusion biopsy compared to standard methods. The system integrates with Philips DynaCAD Urology, streamlining focal therapy planning and delivery while expanding access to minimally invasive treatment options.

Positive

• FDA 510(k) clearance obtained for advanced prostate cancer navigation technology
• 30% improvement demonstrated in high-risk prostate cancer diagnosis accuracy
• Enhanced compatibility with ultrasound devices and integration with existing Philips systems
• Technology enables more precise, minimally invasive treatment options

Negative

• Advanced annotation option requires separate purchase
• Software has limitations in predicting ablation volumes and success

News Market Reaction – PHG

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+3.32% News Effect

On the day this news was published, PHG gained 3.32%, reflecting a moderate positive market reaction.

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July 23, 2025

Supporting prostate cancer diagnosis with more precise guidance for clinicians, offering better patient care

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced a major advancement in image-guided navigation for prostate cancer care with the FDA 510(k) clearance of the latest Philips UroNav version. The system includes a new advanced annotation [1] workflow that supports clinicians during focal therapy procedures, helping deliver more precise, minimally invasive care.

This release comes at a time of increasing need for innovation in prostate cancer care. Prostate cancer remains the most commonly diagnosed solid tumor among men in the United States, with over 313,000 new cases, 1 in 8 men will be diagnosed with prostate cancer in their lifetime [2]. While many prostate cancers are slow-growing, overtreatment can lead to quality-of-life degradation, including incontinence and sexual dysfunction, prompting growing interest in focal therapies that offer a targeted, tissue-sparing alternative for appropriate patients.

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

As an image fusion system, UroNav seamlessly integrates pre-procedural imaging, such as Magnetic Resonance Imaging (MRI), with real-time intra-procedural imaging from ultrasound (US) systems. This innovative combination enhances the precision and accuracy of therapeutic procedures, providing clinicians with a comprehensive and dynamic view of the targeted area.

A more targeted approach means a more informed treatment selection and patients receive better and more precise care and clinicians are supported in better diagnosis, a 30% improvement in high-risk prostate cancer diagnosis using fusion biopsy compared to the standard biopsy [3]. The new advanced annotation workflow works in tandem with DynaCAD Urology to support focal therapy planning, deliver and review, reducing complexity and enabling a broader group of clinicians to offer minimally invasive options.

“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,” said Martijn Hartjes, Business Leader, Clinical Informatics at Philips. “Our goal is to equip clinicians with the clinical tools required so they can deliver better care for more patients.”

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.

[1] The advanced annotation option is sold separately. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success.
[2] Key Statistics for Prostate Cancer. American Cancer Society. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html
[3] 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.

For further information, please contact:

Anna Hogrebe
Philips Global External Relations
Tel.: +1 416 270 6757
E-mail: anna.hogrebe@philips.com  

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.

Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2024 sales of EUR 18 billion and employs approximately 67,200 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

 

Attachments

• DynaCAD urology with advanced annotation
• UroNav cart with advanced annotation option
• UroNav with advanced annotation

FAQ

What is the significance of Philips' FDA 510(k) clearance for UroNav in prostate cancer care?

The clearance allows Philips to offer advanced image-guided navigation technology that combines MRI and ultrasound imaging for more precise prostate cancer diagnosis and treatment, with a demonstrated 30% improvement in high-risk cancer diagnosis.

How does Philips UroNav improve prostate cancer treatment accuracy?

UroNav integrates pre-procedural MRI imaging with real-time ultrasound, providing clinicians with comprehensive dynamic views of targeted areas and supporting more precise focal therapy procedures.

What are the key features of Philips' new UroNav system for prostate cancer care?

Key features include advanced annotation workflow, integration with DynaCAD Urology, enhanced ultrasound device compatibility, upgraded security protections, and seamless fusion of MRI and ultrasound imaging for precise guidance.

What is the current prevalence of prostate cancer in the United States?

According to the press release, there are over 313,000 new cases of prostate cancer in the US, with 1 in 8 men being diagnosed with prostate cancer in their lifetime.

How does Philips' UroNav system benefit patients with prostate cancer?

The system enables more targeted, minimally invasive treatment approaches, helping avoid overtreatment and reducing quality-of-life side effects like incontinence and sexual dysfunction associated with traditional treatments.