FDA Clears Philips’ Latest Image-Guided Navigation for Prostate Cancer

Philips has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for the latest version of its UroNav image-guided navigation for prostate cancer care.

The system features new advanced annotation to support clinicians with focal therapy procedures. UroNav integrates pre-procedural imaging like magnetic resonance imaging (MRI) with real-time, intra-procedural imaging from ultrasound systems. The combination provides clinicians with a comprehensive, dynamic view of the targeted area.

The advanced annotation workflow works with DynaCAD Urology in order to support focal therapy planning, deliver, and review to minimize complexity and enable more clinicians to offer minimally invasive options.

UroNav also provides enhanced compatibility with ultrasound devices and needle guides, upgraded privacy and security protections. It also integrates with Philips DynaCAD systems for radiology and urology.

“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.”

“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.”

Earlier this month, the company earned an FDA nod  for SmartSpeed Precise MR’s latest deep learning reconstruction software. Philips said this is a major milestone toward autonomous, personalized MRI.