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Home » FDA clears Philips’ Smart CT application software

FDA clears Philips’ Smart CT application software

April 6, 2021 By Sean Whooley

Philips SmartCT
[Image from Philips]
Royal Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its Philips SmartCT application software.

Amsterdam-based Philips’ SmartCT software is a component of the company’s Azurion image-guided therapy system for diagnosis, therapy planning, treatment and follow-up for interventional radiology procedures.

SmartCT helps to enhance clinical confidence, smooth the workflow and increase productivity through software applications for angiography, neurology, soft-tissue imaging and guidewire/catheter navigation for procedures that treat aneurysms, vascular disease and liver tumors, among others, according to a news release.

The platform enables control of the Azurion system on a touchscreen tablet situated alongside the interventional radiology table, eliminating the need for clinicians to leave the sterile field and step into an adjacent control room while also supporting faster and better-informed decision-making.

Users of the system are guided through the image acquisition process and can review and interact with CT-like 3D images on the tableside touchscreen through 3D visualization and measurement tools that are designed to support procedures across domains including neurology, oncology and cardiovascular.

“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,” Philips GM of image-guided therapy systems Ronald Tabaksblat said in the release. “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.” 

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Health Technology, Imaging, Regulatory/Compliance, Surgical Tagged With: FDA, Philips

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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