FDA Clears Deep Learning Image Reconstruction for Spotlight CT Scanners

The Food and Drug Adminstration (FDA) has granted 510(k) clearance for the addition of deep learning image reconstruction (DLIR) to the Spotlight™ cardiovascular computed tomography (CT) and Spotlight Duo cardiothoracic CT systems.

Utilizing an advanced convolutional neural network (CNN), the DLIR technology maintains high-contrast spatial resolution while reducing pixel-wise noise magnitude, according to Arineta Cardio Imaging, the manufacturer of the aforementioned CT systems.

Trained on more than three billion image data points, the DLIR technology enhances the use of cross-sectional images for cardiovascular imaging assessment in a variety of settings.

“We have used Arineta cardiac CT systems for several years, and they provide the highest quality cardiac CT clinical images for our practice. From our FDA 510(k) reader study, Arineta’s DLIR technology continues that excellence. Arineta’s SpotLight systems make the highest performance cardiac CT available at point-of-care, in an office, mobile, or cath lab setting,” said Matthew Budoff, M.D., the director of Cardiac Computed Tomography within the Division of Cardiology at the Harbor-UCLA Medical Center in Torrance, Ca.