Elekta’s Evo system combines CT-guided radiation therapy with AI-enhanced imaging designed to support visualization of tumors and nearby organs at risk during treatment.
Elekta announced that its Elekta Evo CT-Linac has today received 510(k) clearance from the US Food and Drug Administration (FDA), making this system available to radiation oncology professionals in the United States.
When delivering radiation therapy, clinicians rely on imaging to identify tumors and nearby organs at risk. Elekta’s Evo system incorporates high-definition, artificial intelligence (AI)-assisted imaging designed to support visualization of target areas and critical structures during each treatment fraction. The system has been adopted by clinics in Europe and other international markets.
“Securing FDA clearance for Elekta Evo is a pivotal step in our commitment to the US market. With Evo, we are empowering American clinics to adopt the latest advances in radiation therapy, delivering more personalized, precise care for their patients,” says Ardie Ermers, executive vice president of the Americas region, in a release.
Compared with conventional cone-beam CT imaging, Elekta Evo incorporates AI-based methods intended to reduce image scatter and support image reconstruction. The approach is designed to improve visualization of anatomical structures during treatment, and the AI-enhanced imaging can be implemented on certain existing Elekta linear accelerators, depending on system configuration.
Eenas Omari, PhD, a member of the radiation oncology team at Medical College of Wisconsin, which was involved in the development of Iris, Elekta’s AI-enhanced imaging technology within the Evo system, says in a release, “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.”
Elekta Evo has CE mark and US FDA 510(k) clearance.
Photo caption: Elekta Evo
Photo credit: Elekta