Siemens Healthineers Receives FDA Clearance for Six Artis Imaging Systems
Siemens Healthineers has announced U.S. Food and Drug Administration (FDA) clearance for six new systems in its Artis interventional imaging portfolio. The systems incorporate the company’s Optiq AI imaging chain, which uses artificial intelligence to optimize image data in real time during image-guided procedures.
According to Siemens Healthineers, the new portfolio is designed to address a broad range of clinical and operational requirements in interventional radiology and image-guided therapy environments.
Six Systems Across Multiple Configurations
The newly cleared systems include:
- Artis vision floor
- Artis vision biplane
- Artis vision ceiling
- Artis vision pheno (floor-mounted robotic system)
- Artis icono.explore floor
- Artis genio floor
The company stated that the systems are intended to support different procedure volumes, workflow requirements, and healthcare facility needs.
Siemens Healthineers noted that the Artis vision systems are designed for high-speed and precision-focused image-guided procedures. The Artis icono.explore floor system is intended for environments with high patient throughput, while the Artis genio floor configuration is positioned as a versatile system for a broad procedural mix.
AI-Based Imaging Optimization
At the center of the new portfolio is the Optiq AI imaging chain, which applies deep-learning-based noise reduction across multiple 2D imaging modes, including:
- Fluoroscopy
- Acquisition imaging
- Digital subtraction angiography (DSA)
According to Siemens Healthineers, the AI technology analyzes and optimizes image data in real time to support consistent image quality during interventional procedures.
“As more complex procedures come to interventional labs, increased precision is of paramount importance,” said Kris McVey, head of Angiography in the Advanced Therapies business at Siemens Healthineers North America. “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,” McVey added.
Additional Workflow and Imaging Features
The Artis portfolio also includes workflow and imaging capabilities designed to support interventional teams during procedures.
Siemens Healthineers highlighted advanced 3D imaging applications such as syngo DynaCT MORE, which is designed to reduce motion-related artifacts during intraprocedural 3D imaging.
The company also noted that the Touch UI touchscreen interface allows tableside access to system functions and supports direct interaction between physicians and technologists during procedures.
According to Siemens Healthineers, standardized controls across the Artis portfolio are intended to reduce variability between procedure rooms and support workflow consistency for clinical teams.
The FDA-cleared systems are part of Siemens Healthineers’ broader interventional imaging portfolio for image-guided therapy applications in interventional radiology, cardiology, and vascular procedures.
Source: Siemens Healthineers
