Elekta Evo Linear Accelerator Wins FDA Nod

Elekta has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Elekta Evo CT-Linac.

For radiation therapy, clinicians need high-quality images to identify tumors and organs at risk. Evo uses Iris high-definition, artificial intelligence (AI)-enhanced imaging to let physicians see target areas and critical structures for every fraction.

Rather than conventional cone-beam CT imaging, Evo uses AI to scatter and enhance image reconstruction. According to the company, this leads to clearer images and helps clinicians see structures more accurately to support decision-making.

“Securing FDA clearance for Elekta Evo is a pivotal step in our commitment to the U.S. market,” said Ardie Ermers, executive VP, region Americas at 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.”

Iris’ AI-enhanced image quality was designed to allow for easy upgrading on existing Elekta linacs. This depends on the specific linac version, the company should be contacted to learn more.

“Iris provides enhanced image quality,” said Eenas Omari, Ph.D., a member of the radiation oncology team at Medical College of Wisconsin. “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.”

In July 2025, the company won an FDA nod for new indications on its Leksell Gamma Knife radiosurgery system. They include clearance for refractory, intractable mesial temporal lobe epilepsy (MTLE) in adults.