Elekta Evo submitted to U.S. FDA for premarket approval – to be featured at ASTRO
STOCKHOLM – Elekta (EKTA-B.ST) announced today that its AI-powered adaptive CT-Linear Accelerator, Elekta Evo* has been submitted and is now pending 510(k) premarket approval from the U.S. Food and Drug Administration (FDA) – this, less than a week after Evo received CE mark for sales and marketing in the European Union.
Ardie Ermers, Elekta’s Executive Vice President, Region Americas, said: “We are thrilled to announce the submission of Evo for 510(k) clearance. Designed to enhance patient outcomes and streamline clinical workflows, Evo represents a significant leap forward in adaptive treatment capabilities. We look forward to bringing this innovative solution to healthcare providers and patients across the U.S.”
To learn more about Evo and Elekta’s other advanced precision radiation therapy solutions, visit booth #2227 at the American Society for Radiation Oncology (ASTRO) Annual Meeting in Washington, D.C., September 29-October 2, or visit: elekta.com/ASTRO.
*Elekta Evo is CE marked with limited global availability, pending U.S. FDA 510(k) premarket clearance and is not available for commercial distribution or sale in the U.S.
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For further information, please contact:
Mattias Thorsson, Vice President, Head of Corporate Communications
Tel: +46 70 865 8012, e-mail: Mattias.Thorsson@elekta.com
Time zone: CET: Central European Time
Raven Canzeri, Global Director, Media Relations
Tel: +1 770-670-2524, e-mail: Raven.Canzeri@elekta.com
Time zone: ET: Eastern Time
About Elekta
As a leader in precision radiation therapy, Elekta is committed to ensuring every patient has access to the best cancer care possible. We openly collaborate with customers to advance sustainable, outcome-driven and cost-efficient solutions to meet evolving patient needs, improve lives and bring hope to everyone dealing with cancer. To us, it's personal, and our global team of 4,700 employees combine passion, science, and imagination to profoundly change cancer care. We don’t just build technology, we build hope. Elekta is headquartered in Stockholm, Sweden, with offices in more than 40 countries and listed on Nasdaq Stockholm. For more information, visit elekta.com or follow @Elekta on “X”, formerly known as Twitter.