Siemens Healthineers scores FDA clearance for 6 interventional systems

The U.S. Food and Drug Administration just cleared several interventional systems manufactured by Siemens Healthineers. 

The medical technology giant on Tuesday announced the clearance of six systems in its Artis interventional imaging portfolio. The clearances cover multiple configurations, including the floor, biplane, ceiling and pheno (or floor-mounted robotic) versions of the Artis vision platform, plus floor setups for the Artis icono.explore and Artis genio platforms. 

Each system comes equipped with Siemens’ new artificial intelligence-powered Optiq AI imaging chain. This feature was designed to deliver high quality imaging at lower radiation doses during IR procedures. The algorithm automatically adjusts tube voltage, tube current, copper prefiltration, focal spot size, pulse width and detector dose in real-time while simultaneously optimizing source-image distance and collimation, even during repositioning movements. This feature was introduced in late 2025 during the annual RSNA conference in Chicago. 

“As more complex procedures come to interventional labs, increased precision is of paramount importance,” Kris McVey, head of Angiography in the Advanced Therapies business at Siemens Healthineers North America, said in a news release. “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.” 

Each system was designed with specific needs in mind, Siemens said. The four in the Artis vision platform provide enhanced speed and precision, while the floor version of the Artis icono.explore is well suited for departments with high throughput; the Artis genio floor system also was designed for high throughput clinics, but comes with advanced features designed to help more complex IR procedures run smoothly and is suited for a diverse caseload.