FDA Clears Siemens Healthineers SOMATOM X.cite CT Scanner with Intelligent User Interface

The U.S. Food and Drug Administration (FDA) has cleared the new SOMATOM X.cite premium single-source computed tomography (CT) scanner from Siemens Healthineers and the new myExam Companion intelligent user interface concept. The intuitive user interface of the myExam Companion guides the user through the exam workflow with precise questions about the patient, potentially enabling optimization of the state-of-the-art features of a premium CT scanner such as the SOMATOM X.cite. The myExam Companion combines available patient data such as gender and age with other user or machine-observable, patient-specific information—for example, a patient’s electrocardiogram (ECG) waveform for a cardiac study—to identify optimal acquisition and reconstruction techniques for each patient. 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 (CTA) studies.
 
The first CT scanner launching with the myExam Companion intelligent user interface concept, the SOMATOM X.cite uses the Vectron X-ray tube, which was previously available only on the SOMATOM Force dual source CT scanner. In combination with a large 82cm gantry bore, the SOMATOM X.cite offers advanced imaging capabilities with an even greater focus on patient comfort.
 
The myExam Companion enables technologists to utilize the full potential of not only the SOMATOM X.cite, but also the scanners of the SOMATOM go. CT platform.¹ Siemens Healthineers analyzed nearly 200,000 scan protocols using artificial intelligence and tapped clinical experts to identify key questions regarding the framework conditions for an optimized scan result. On this basis, Siemens Healthineers designed scan strategies and clinical decision trees to aid in proper setup and scanner operation. At its core, the myExam Companion renders complicated clinical decision-making into these 20-plus, user-definable clinical decision trees that are displayed at the human-machine interface, either at the operator console or using the scanner’s mobile, detachable tablets. These clinical decision tree workflows are sharable across the institution.
 
“Lack of staff and time and the creation of standards are some of the biggest hurdles in the daily business of radiology,” said André Hartung, president of Diagnostic Imaging at Siemens Healthineers. “With the SOMATOM X.cite and the myExam Companion, we provide our customers with unique tools to overcome these hurdles effectively. It is a major step for our imaging portfolio into the world of intelligent user support and for Siemens Healthineers on our way to becoming a leader in clinical decision support.”
 
In addition to its large, 82cm gantry bore and optional Moodlight feature, the SOMATOM X.cite includes the Patient Observation Camera. This new 2D visualization camera allows the technologist to closely monitor the patient while he or she is inside the gantry for potentially fewer patient motion artifacts. The SOMATOM X.cite also includes Visual Patient Instruction, a new visual breath hold indicator on the gantry that guides the patient through the breath hold process with color-guided visual instructions.
 
Together, these features create a holistic, patient-centric scanning experience.
 
The technologist can control scan preparation and oversee the scan via a detachable, gantry-mounted tablet, enabling the technologist to remain with the patient until immediately before the scan. An optional FAST Integrated Workflow with FAST 3D Positioning Camera collects further anatomical information and automatically positions the patient at isocenter. The Vectron X-ray tube enables a maximum 1,200 mA High Power mode at low 70 or 80 kV stations; low kV scanning with significant power reserves enables lowering of radiation dose and contrast media volumes. Together with the Stellar Infinity detector, the Vectron tube enables visualization of even the smallest details with 0.30 mm precision resolution. To further personalize the scanning process, the SOMATOM X.cite is capable of fine-tuned 10 kV steps, enabling a greater range of personalized dose modulation.
 
Siemens Healthineers AG is shaping the future of healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care to patients. In fiscal 2019, which ended on Sept. 30, 2019, Siemens Healthineers, which has approximately 52,000 employees worldwide, generated revenue of 14.5 billion euros and adjusted profit of 2.5 billion euros. 

Reference
¹ The SOMATOM.go systems with my Exam Companion are pending 510(k) clearance, and are not yet commercially available in the United States.