Siemens Healthineers has received U.S. Food and Drug Administration (FDA) clearance for its artificial intelligence (AI)-based software for visualization of CT images of the lungs, heart, and aorta.
The FDA cleared three modules of Siemens' AI-Rad Companion Chest CT software, which helps radiologists quickly interpret chest images, the company said. The software differentiates among the lungs, heart, and aorta, highlighting them individually and marking potential abnormalities such as coronary calcifications.
The software also generates standard reports in DICOM SC format and flags clinically relevant changes that might have gone unnoticed since they were not the primary indication for the exam, according to the firm.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
