Philips advances minimally invasive therapy procedures in prostate cancer care with FDA 510(k) clearance for image-guided navigation technology
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.
Philips (NYSE: PHG) ha ottenuto l'autorizzazione FDA 510(k) per la sua ultima versione di UroNav, migliorando la tecnologia di navigazione guidata da immagini per la cura del cancro alla prostata. Il sistema presenta un nuovo flusso di lavoro avanzato per l'annotazione che potenzia le procedure di terapia focale grazie a una maggiore precisione nelle cure minimamente invasive.
La tecnologia combina immagini MRI pre-procedurali con ultrasuoni in tempo reale per una precisione terapeutica superiore. I dati clinici mostrano un miglioramento del 30% nella diagnosi del cancro alla prostata ad alto rischio utilizzando la biopsia fusion rispetto ai metodi standard. Il sistema si integra con Philips DynaCAD Urology, semplificando la pianificazione e l'esecuzione della terapia focale e ampliando l'accesso alle opzioni di trattamento minimamente invasive.
Philips (NYSE: PHG) ha recibido la autorización FDA 510(k) para su última versión de UroNav, avanzando en la tecnología de navegación guiada por imágenes para el cuidado del cáncer de próstata. El sistema cuenta con un nuevo flujo de trabajo avanzado de anotación que mejora los procedimientos de terapia focal mediante una mayor precisión en el cuidado mínimamente invasivo.
La tecnología combina imágenes de MRI pre-procedimiento con ultrasonido en tiempo real para una mayor precisión terapéutica. Los datos clínicos muestran una mejora del 30% en el diagnóstico de cáncer de próstata de alto riesgo utilizando biopsia por fusión en comparación con los métodos estándar. El sistema se integra con Philips DynaCAD Urology, facilitando la planificación y ejecución de la terapia focal mientras amplía el acceso a opciones de tratamiento mínimamente invasivas.
필립스(NYSE: PHG)가 최신 UroNav 버전에 대해 FDA 510(k) 승인을 받으며 전립선암 치료를 위한 영상 유도 내비게이션 기술을 발전시켰습니다. 이 시스템은 최소 침습 치료의 정밀도를 향상시키는 새로운 고급 주석 워크플로우를 특징으로 하여 국소 치료 절차를 강화합니다.
이 기술은 시술 전 MRI 영상과 실시간 초음파를 결합하여 치료 정확도를 높입니다. 임상 데이터에 따르면 융합 생검을 사용한 경우 표준 방법에 비해 고위험 전립선암 진단이 30% 향상된 것으로 나타났습니다. 이 시스템은 Philips DynaCAD Urology와 통합되어 국소 치료 계획 및 실행을 간소화하고 최소 침습 치료 옵션에 대한 접근성을 확대합니다.
Philips (NYSE : PHG) a obtenu l'autorisation FDA 510(k) pour sa dernière version d'UroNav, faisant progresser la technologie de navigation guidée par l'image pour les soins du cancer de la prostate. Le système propose un nouveau flux de travail avancé d'annotation qui améliore les procédures de thérapie focale grâce à une précision accrue dans les soins peu invasifs.
La technologie combine imagerie IRM pré-procédurale avec échographie en temps réel pour une précision thérapeutique renforcée. Les données cliniques montrent une amélioration de 30 % du diagnostic du cancer de la prostate à haut risque grâce à la biopsie par fusion, comparativement aux méthodes standards. Le système s'intègre à Philips DynaCAD Urology, facilitant la planification et la réalisation de la thérapie focale tout en élargissant l'accès aux options de traitement peu invasives.
Philips (NYSE: PHG) hat die FDA 510(k)-Zulassung für seine neueste UroNav-Version erhalten und damit die bildgeführte Navigationstechnologie für die Prostatakrebsbehandlung weiterentwickelt. Das System verfügt über einen neuen erweiterten Annotations-Workflow, der fokale Therapieverfahren durch verbesserte Präzision bei minimalinvasiven Behandlungen optimiert.
Die Technologie kombiniert prä-prozedurale MRT-Bildgebung mit Echtzeit-Ultraschall für eine verbesserte therapeutische Genauigkeit. Klinische Daten zeigen eine 30%ige Verbesserung bei der Diagnose von Hochrisiko-Prostatakrebs durch Fusionsbiopsie im Vergleich zu Standardmethoden. Das System integriert sich in Philips DynaCAD Urology und erleichtert die Planung und Durchführung der fokalen Therapie, während es den Zugang zu minimalinvasiven Behandlungsoptionen erweitert.
- 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
- Advanced annotation option requires separate purchase
- Software has limitations in predicting ablation volumes and success
Insights
Philips' FDA clearance for UroNav enhances prostate cancer focal therapy with improved imaging precision, strengthening their position in urology technology.
Philips has secured FDA 510(k) clearance for its latest UroNav version featuring an advanced annotation workflow specifically designed for prostate cancer focal therapy procedures. This regulatory milestone significantly enhances Philips' position in the urological technology market.
The technology creates value through image fusion, seamlessly integrating pre-procedural MRI imaging with real-time ultrasound during procedures. This integration delivers crucial clinical benefits: a
The strategic importance lies in Philips' approach to addressing the prostate cancer treatment paradigm shift. With over 313,000 new cases annually in the US alone and concerns about overtreatment leading to incontinence and sexual dysfunction, the market is increasingly demanding focal therapy options that deliver precision without compromising quality of life.
This approval strengthens Philips' comprehensive urology portfolio that integrates imaging, biopsy, therapy guidance, and digital pathology. The enhanced UroNav system delivers improved compatibility with ultrasound devices and needle guides, upgraded security, and seamless integration with Philips DynaCAD systems. This positions Philips to capture market share in the growing minimally invasive prostate treatment segment while addressing the clinical need for targeted approaches that minimize side effects while maintaining treatment efficacy.
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
“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
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