Izotropic Obtains Patent Rights to Computer-Aided Diagnosis for Breast CT

Izotropic Corporation has secured the only U.S. patent for computer-aided diagnosis with breast computed tomography (CT), covered by its exclusive global license agreement to breast CT technology with the Regents of the University of California.

Computer-aided diagnosis (CADx) is an artificial intelligence (AI) software-based tool used in radiology to support physicians in interpreting medical images by analyzing them to estimate the likelihood of malignancy. In breast imaging, CADx has become an area of focus to address the limitations of various imaging modalities, improve diagnostic performance, and support radiologists in making faster, more confident decisions.

For example, mammography, digital breast tomosynthesis (DBT), and ultrasound can miss cancers due to overlapping tissue, breast density, or operator variability. CADx is being developed to address these limitations by flagging subtle abnormalities that may be missed during initial review. These systems aim to improve cancer detection in cases where the imaging modality itself may not fully visualize an abnormality. In MRI, CADx can play a different but equally important role. MRI, like breast CT, produces larger volumes of detailed imaging data that therefore take more time to interpret. CADx is being increasingly used to support radiologists by triaging exams, highlighting abnormal regions, and reducing read times to improve overall efficiency. In all applications, CADx is being developed to support more consistent interpretation, reduce diagnostic uncertainty, and streamline clinical workflows.

Izotropic’s flagship IzoView Breast CT Imaging System is being commercialized as a true 3D breast-dedicated imaging alternative that bridges the gap between DBT and MRI, with an initial use indication for contrast-enhancement for adjunctive breast cancer screening in asymptomatic patients with dense breast tissue.  

While IzoView will not initially launch with a CADx feature, it will be sold with the integration of a trade-secret machine-learning image reconstruction algorithm developed for real-world clinical workflows. This algorithm optimizes IzoView’s images by addressing CT imaging noise while overcoming the limitations of existing methods, and maintaining low radiation doses comparable to two-view mammography.

The company plans to integrate CADx into IzoView as a post-market feature, available through a software upgrade after additional market authorizations. The feature may be offered as an incentive to early adopters, supporting clinical value while contributing to future software-based revenue opportunities.

Izotropic Corporation holds the exclusive global licensing rights to breast CT technology from the Regents of the University of California. This technology was originally developed at the University of California, Davis, under the Breast Tomography Project led by Company Director Dr. John Boone and his clinical collaborators. Four successive breast CT research devices were developed and evaluated at UC Davis. IzoView has not been approved or cleared by any regulatory authority and is not yet available for commercial sale.