Issue: May 2021

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April 06, 2021
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FDA grants clearance for 3D CT image acquisition software

Issue: May 2021
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Royal Philips announced the FDA granted 510(k) clearance for its 3D CT image acquisition, visualization and measurement application software for interventional radiology procedures.

According to a press release, the new software (SmartCT, Philips) is designed to work with the Philips’ guided therapy system (Azurion) and provide interventionalists with CT-like 3D images to support diagnosis, therapy planning, treatment and follow-up for interventional radiology procedures.

FDA approval
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Users of the image acquisition software are guided through the image acquisition process and can review and interact with image using a table-side touch screen module which features two-point distance measurements on 3D images, the ability to remove structures from the images that obstruct the region of interest and the ability to select and store optimum projection angles for recall during procedures, according to the release.

“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,” Ronald Tabaksblat, general manager of image guided therapy systems at Philips, 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.”