Royal Philips has obtained US Food and Drug Administration’s (FDA) 510(k) clearance for its latest version of the Philips UroNav system to be used as an image-guided navigation technology for prostate cancer care.
The updated system introduces an advanced annotation workflow to assist clinicians in providing precise, minimally invasive focal therapy procedures.
According to Philips, this development arises amid a rising demand for innovative prostate cancer treatments. In the US, prostate cancer is the most frequently diagnosed solid tumour among men, with over 313,000 new cases each year.
With the likelihood of one in eight men being diagnosed during their lifetime, there is growing interest in focal therapies that offer targeted, tissue-sparing alternatives to avoid overtreatment and minimise quality-of-life issues such as incontinence and sexual dysfunction.
Philips clinical informatics business leader Martijn Hartjes said: “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.
“Our goal is to equip clinicians with the clinical tools required so they can deliver better care for more patients.”
Philips UroNav combines pre-procedural magnetic resonance imaging (MRI) with real-time ultrasound imaging to enhance precision and accuracy in therapeutic procedures. This integration provides clinicians with a comprehensive view of the targeted area, facilitating improved treatment selection and diagnosis.
It has been observed that fusion biopsy can result in a 30% improvement in diagnosing high-risk prostate cancer compared to standard biopsy methods.
The system also offers compatibility with various ultrasound devices and needle guides while ensuring upgraded privacy and security features. Its integration with Philips DynaCAD systems enhances its clinical functionality for both radiology and urology applications.
Philips UroNav supports both transrectal and transperineal biopsy approaches, providing flexibility in incorporating fusion-guided biopsy into preferred methods.
By fusing diagnostic MR images of the prostate with live ultrasound images, it delivers clear delineation of the prostate and suspicious lesions. The ability to preview MR images and assess gland segmentation and biopsy targets before procedures allows urologists to conduct biopsies with increased confidence.