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United Imaging uCT ATLAS Earns FDA Clearance

United Imaging has announced FDA clearance for the uCT ATLAS, the latest in the company’s computed tomography (CT) portfolio of scanners and the 25th FDA clearance for the company overall.

FDA Clears SOMATOM X.ceed Premium Single-Source CT Scanner

Siemens Healthineers has announced the Food and Drug Administration (FDA) clearance of the SOMATOM X.ceed, a single-source computed tomography scanner that combines high-speed scanning capabilities and a level of resolution previously unseen in other single-source CT systems with a new hardware/software combination to simplify CT-guided interventions. Possessing the largest bore for a diagnostic CT scanner at 82 cm, the scanner is designed for all diagnostic procedures, particularly cardiac and trauma imaging.

“With these and other features, the SOMATOM X.ceed expands precision medicine and transforms care delivery,” a news release states.

“Several key design features of the SOMATOM X.ceed differentiate it from other single-source CT scanners. It has the fastest rotation speed¹ on a single-source CT at 0.25s to ensure a high native temporal resolution and reduce motion artifacts when scanning moving structures such as the heart,” the release states. “It possesses the fastest scan speed¹ at 262mm/s for consistent image quality across the entire field of view. Additionally, the scanner has the smallest focal point¹, at 0.4×0.5, for increased spatial resolution to better aid in the detection of deep-seated small and medium lesions. And with 1300 mA power reserves, it also has the highest power,¹ enabling a high level of image quality for larger patients while expanding the utilization of low dose and low contrast media techniques, such as low kV imaging.”

A key feature of the SOMATOM X.ceed is myNeedle Companion, a new approach to CT-guided interventions that combines hardware innovations and intuitive software to

coordinate the planning and guidance of percutaneous needle procedures. One version of myNeedle Companion includes myNeedle 3D, a fully integrated software package that supports complex interventional procedures and includes as an option the world’s first scanner-integrated laser guidance system. Established myExam Companion user guidance software employs artificial intelligence to help simplify and standardize scanner operation for each user. myExam Companion also provides a new decision tool for trauma imaging, and the new myExam Satellite feature allows immediate assessment of CT perfusion results, which can be valuable in emergency radiology.

“With the SOMATOM X.ceed, Siemens Healthineers expands its portfolio of high-end, single-source CT scanners that leverages the myExam Companion intelligent user interface to standardize and streamline workflows as well as provide optimal image quality at the lowest possible dose,” said Douglas Ryan, Vice President of the Computed Tomography business at Siemens Healthineers North America. “The addition of myNeedle Companion can help healthcare professionals perform simple and complex interventional procedures with greater confidence. And the high image quality resulting from the scanner’s fast rotation and scan speeds, coupled with its high resolution, can help lead to more informed decisions.”

For further information on the SOMATOM X.ceed, please see siemens-healthineers.us/somatom-xceed.

¹ Based on competitive literature available at time of publication. Data on file.

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