Philips SmartCT 3D image acquisition, visualization and measurement software for its Azurion Image Guided Therapy System receives FDA 510(k) clearance

April 6, 2021

• Intuitive, table-side touchscreen control offers interventionalists enhanced diagnostic confidence and streamlined workflows [1]
• Full control of image acquisition and analysis from within the sterile zone helps to avoid procedure disruption, saving time and allowing interventionalists to stay focused on their patients

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced U.S. Food and Drug Administration 510 (k) clearance for its Philips SmartCT application software. SmartCT is a key component of Philips Image Guided Therapy System – Azurion – providing interventionalists with CT-like 3D images (Cone Beam CT) to support diagnosis, therapy planning, treatment and follow-up for interventional radiology procedures. Bringing intuitive touchscreen control of advanced 3D image acquisition, visualization, vessel/organ segmentation, and quantitative measurements to the table-side, within the interventional lab’s sterile zone, SmartCT helps enhance clinical confidence, smooths workflows, and increases productivity. It includes software applications for angiography, neurology, soft-tissue imaging, and guidewire/catheter navigation, supporting a wide range of procedures such as the treatment of aneurysms, vascular diseases and liver tumors.

Philips’ latest Azurion image-guided therapy platform integrates essential lab systems and tools needed for complex interventional procedures into an uncluttered laboratory environment in which interventionalists can focus on treating the patient rather than being distracted by the technology. SmartCT brings total control of the Azurion platform to a touchscreen tablet situated alongside the interventional radiology table. This eliminates the need for clinicians to leave the sterile field and step into an adjacent control room, as well as supporting faster and better-informed decision making.

“A key part of our image-guided therapy strategy is to combine high-quality, low X-ray dose imaging with a superior user experience that allows interventional radiologists to diagnose and treat patients as part of smoother, safer and less interrupted workflows,” said Ronald Tabaksblat, General Manager Image Guided Therapy Systems at Philips. “Philips SmartCT is a major step forward in 3D imaging, enhancing confidence in the interventional suite and supporting key elements of the quadruple aim of better patient outcomes, enhanced patient and staff experiences and lower cost of care.”