Siemens Healthineers scores FDA approval for intelligent new CT scanner

Germany-based Siemens Healthineers has earned clearance from the Food and Drug Administration for a new CT imaging device that’s powered by artificial intelligence.

The SOMATOM X.cite premium single-source computed tomography scanner—when paired with myExam Companion—guides radiologists through each step of the exam process. Step-by-step instructions are built upon patient data and other machine-observable, patient-specific info to help guide optimal image acquisition techniques.

“Together, these innovations make the imaging process more efficient, compensating for differences in user experience levels and scan complexities on even the most complicated acquisitions, including coronary CT angiography studies,” Siemens said in a Thursday, Nov. 21, announcement.


This is the first CT scanner launched using myExam Companion. Siemens analyzed almost 200,000 scan protocols using artificial intelligence to build the interface, with clinical experts also contributing feedback. It helps to distill “complicated clinical decision-making” into about 20 decision trees displayed on the interface.

“Lack of staff and time and the creation of standards are some of the biggest hurdles in the daily business of radiology,” André Hartung, president of diagnostic imaging at Siemens, said in a statement

The company also recently scored FDA clearance in the fall for another AI application—a cloud-based solution that assists providers by scanning CT images and identifying potential abnormalities in a patient’s lungs, heart and aorta.