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FDA Clears Six Siemens Healthineers' New Artis Interventional Imaging Systems

May 13, 2026 · News Release

FDA Clears Six Siemens Healthineers' New Artis Interventional Imaging Systems

Siemens Healthineers has secured clearance from the U.S. Food and Drug Administration (FDA) for six advanced interventional systems within its Artis imaging line, which now features the Optiq AI imaging chain. This cutting-edge technology leverages artificial intelligence to enhance the quality of image-guided therapy by optimizing image data in real-time. The systems cleared include various configurations from the Artis vision icono. explore, and genio platforms, designed to meet diverse clinical, operational, and financial needs.

The newly approved systems comprise different configurations, including floor, biplane, ceiling, and pheno (or floor-mounted robotic) models within the Artis vision platform, as well as specific floor configurations of the Artis icono. explore and Artis genio platforms. The Optiq AI technology is central to these systems, providing deep-learning-based noise reduction across several 2D imaging modes such as fluoroscopy and digital subtraction angiography. This technology ensures consistent high-quality imaging during interventional procedures.

Kris McVey, head of Angiography for Siemens Healthineers North America, emphasized the importance of precision in interventional labs, noting that "Our new Artis portfolio powered by Optiq AI delivers the high level of image quality clinicians rely upon to guide these intricate procedures—while taking into account the needs and budget of every type of healthcare facility."

The Artis imaging portfolio offers extensive features aimed at elevating procedural capabilities and delivering a standardized user experience. Inclusion of advanced 3D applications, like syngo DynaCT MORE, enhances intraprocedural imaging by minimizing motion-related artifacts. Moreover, the Touch UI interface provides intuitive tableside access to essential system operations, fostering collaboration between physicians and technologists. The uniformity in controls across the platform aids in reducing variability as medical teams transition between different rooms.

These innovations position Siemens Healthineers as a leading player in the domain of medical imaging, reinforcing their commitment to integrating advanced technology, such as artificial intelligence, to improve clinical outcomes and efficiency in healthcare settings. 

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