The US Food and Drug Administration (FDA) has granted 510(k) clearance for Philips’ latest UroNav version, marking an advancement in image-guided navigation for prostate cancer care.

Philips UroNav is said to include a new annotation workflow designed to work with DynaCAD Urology, aiding clinicians during focal therapy procedures, offering a minimally invasive care approach.

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This image fusion system combines pre-procedural magnetic resonance imaging (MRI) with real-time intra-procedural ultrasound imaging, increasing the accuracy of therapeutic procedures and providing a comprehensive view of the target area.

It accommodates both transrectal and transperineal biopsy methods, allowing clinicians to integrate fusion-guided biopsy according to their preferred approach.

During procedures, the clinical team can review biopsy targets and core samples during a 3D procedure, assisting in the identification of biopsy sample areas.

Additionally, UroNav facilitates viewing and exporting screen captures and video recordings from the fusion-guided biopsy.

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Philips noted that UroNav provides improved compatibility with various ultrasound devices and needle guides, upgraded privacy and security features, and integration with Philips DynaCAD systems for urology and radiology.

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.” 

The company’s comprehensive urology portfolio is said to integrate biopsy, imaging, therapy guidance, and digital pathology, enabling clinicians to provide precision diagnosis and treatment.

Earlier this month, the agency granted 510(k) clearance for Philips’ SmartSpeed Precise deep learning reconstruction software.

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