Elekta has received 510(k) FDA clearance for its Evo linear accelerator, expanding access to the system for radiation oncology providers across the United States.

The Evo CT-Linac integrates AI-driven imaging through Elekta’s Iris technology, which uses high-definition reconstruction to enhance soft tissue contrast and reduce artifacts. The Stockholm-based company said the system supports improved visualization of tumors and nearby organs during treatment, potentially increasing precision in targeting.

According to the company, the Iris platform can also be installed as an upgrade on some existing Elekta linear accelerators, depending on the model.
“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. “With Evo, we are empowering American clinics to adopt the latest advances in radiation therapy, delivering more personalized, precise care for their patients.”

The Medical College of Wisconsin was involved in the development of the Iris imaging system. Eenas Omari, Ph.D., a member of the institution’s radiation oncology team, noted that the improved image quality helps with daily guidance and adapting to anatomical changes during treatment. “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,” Omari said.

Evo received CE marking in Europe prior to the FDA clearance and is already in clinical use in several non-U.S. markets. Elekta says the system’s imaging upgrades are designed to support both new installations and existing linacs, although availability may vary by region.

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