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Home » Siemens Healthineers wins FDA clearance for 6 new interventional imaging systems

Siemens Healthineers wins FDA clearance for 6 new interventional imaging systems

May 12, 2026 By Sean Whooley

Siemens Healthineers Six FDA clearances for interventional tech
Interventional imaging platforms cleared with the Optiq AI imaging chain. [Image courtesy of Siemens Healthineers]
Siemens Healthineers announced today that the FDA cleared six new systems within its Artis interventional imaging portfolio.

The new interventional systems include the floor, biplane, ceiling and pheno (or floor-mounted robotic) versions of the Artis vision platform. It also includes the floor configurations of the Artis Icono.Explore and Genio platforms. Siemens Healthineers offers the Optiq AI imaging chain for all six systems, using AI to analyze and optimize image data in real time.

According to Siemens Healthineers, its six new systems address a wide range of clinical uses, operational needs and financial considerations. Its four Artis platform systems deliver high speed and precision for image-guided procedures. Artis Icono.Explore offers high patient throughput, while the company labeled Artis Genio as a “workhorse system” capable of versatility and high productivity in a broad case mix.

Unifying all six cleared platforms is Optiq AI, which applies deep-learning-based noise reduction across 2D imaging modes. These include fluoroscopy, acquisition and digital subtraction angiography. Siemens Healthineers said the denoising enables consistent, high-quality visualization during interventional procedures.

Additional new features in the portfolio include advanced capabilities across procedures and a standardized user experience. It has advanced 3D applications and new touch screen functions alongside consistent controls across the portfolio.

“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.”

Filed Under: 510(k), Artificial Intelligence (AI), Food & Drug Administration (FDA), Health Technology, Imaging, Machine Learning (ML), Regulatory/Compliance Tagged With: FDA, Siemens Healthineers

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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