FDA Clears Philips SmartCT 3D-Image Software for Its Azurion System

April 6, 2021—Royal Philips announced FDA 510(k) clearance for the Philips SmartCT application software, which is a key component of Azurion, Philips’ image-guided therapy system. The software provided interventionists with CT-like three-dimensional (3D) images (cone-beam CT) to support diagnosis, therapy planning, treatment, and follow-up for interventional radiology procedures.

According to the company, SmartCT brings 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. 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.

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, stated Philips.

“Changing to a new technology can be challenging, but if the system itself can show you the way, it makes it much easier to adopt new advances,” commented Professor Hicham Kobeiter, MD, in Philips’ announcement. “SmartCT leads you through each step of the procedure, bringing us more confidence and more precision across cardiovascular, oncology, and emergency cases.” Prof. Kobeiter is Chief of Radiology and Interventional Radiology, Hôpitaux Universitaires Henri-Mondor in Crétiel, France.

Professor Marc Sapoval added, “With the new SmartCT interface we can go into more detail more quickly and safely, with fewer staff in the room. SmartCT has brought cone-beam CT to life in everyday practice; all the tools and guidance capabilities are used by the entire team each day.” Prof. Sapoval is an interventional radiologist at Hôpital Européen Georges Pompidou AP-HP in Paris, France.