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Home » Elekta gets FDA nod for AI-powered linear accelerator for radiology

Elekta gets FDA nod for AI-powered linear accelerator for radiology

January 16, 2026 By Sean Whooley

Elekta Evo radiation system
The Evo linear accelerator. [Image courtesy of Elekta]
Elekta announced today that its Evo CT linear accelerator (linac) received FDA 510(k) clearance, making it available to U.S. radiation oncology professionals.

Evo uses Iris high-definition, AI-enhanced imaging to help deliver high-quality images that enable clinicians to identify at-risk organs and tumors when delivering radiation therapy. The platform allows physicians to see target areas and critical structures for every fraction with greater clarity.

Already available in Europe, Evo continues to gain traction, Elekta said in a news release. The company believes it sets “new benchmarks” in radiation therapy as more clinics adopt the technology.

Unlike conventional cone-beam computed tomography (CT) imaging, Evo uses AI to reduce scatter and enhance image construction. This, Elekta says, leads to clearer images and helps clinicians see structures more accurately. Altogether, it supports better decision-making. Iris features AI-enhanced image quality to allow for easy upgrading on existing Elekta linacs as well.

“Securing FDA clearance for Elekta Evo is a pivotal step in our commitment to the U.S. market. With Evo, we are empowering American clinics to adopt the latest advances in radiation therapy, delivering more personalized, precise care for their patients,” said Ardie Ermers, Elekta EVP, Americas. “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.”

Filed Under: Artificial Intelligence (AI), Health Technology, Imaging, Machine Learning (ML), Oncology, Radiosurgery/Radiation therapy, Software / IT Tagged With: Elekta, FDA

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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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