FDA Clears Elekta Evo CT-Linac, Bringing AI-Driven Imaging to U.S. Radiation Oncology

Elekta (EKTA-B.ST) announced that its Elekta Evo CT-Linac has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making the system available to radiation oncology professionals across the United States.

High-quality imaging is critical in radiation therapy to accurately identify tumors and protect organs at risk. Elekta Evo addresses this need with Iris® high-definition, AI-enhanced imaging, which enables clinicians to visualize target areas and critical structures with greater clarity for every treatment fraction. Already in use in Europe and other regions, Evo has gained traction as clinics adopt its advanced treatment and imaging capabilities.

“Securing FDA clearance for Elekta Evo is a pivotal step in our commitment to the U.S. market,” said Ardie Ermers, Executive Vice President, Region Americas, Elekta. “With Evo, we are empowering American clinics to adopt the latest advances in radiation therapy, delivering more personalized, precise care for their patients. Our strategy is to ensure that every provider, regardless of size or location, can access innovative solutions that improve outcomes and operational efficiency. Evo’s versatility and AI-driven imaging set a new standard for cancer care in the United States.”

The Iris imaging platform was developed with clinical collaboration, including the Medical College of Wisconsin. According to Eenas Omari, PhD, a member of the radiation oncology team involved in Iris development, “Iris provides enhanced image quality. The reduction in artifacts and improved soft tissue contrast not only enhance daily image guidance for precise patient positioning but also allows us to see anatomical changes with greater confidence. This capability maximizes targeting precision and truly personalizes care for each patient.”

Unlike conventional cone-beam CT imaging, Evo leverages AI to reduce scatter and enhance image reconstruction, resulting in clearer images and improved visualization of anatomical structures to support clinical decision-making. Iris’s AI-enhanced image quality has also been designed to enable upgrades on existing Elekta linacs, depending on system configuration.