Mevion Medical Systems Receives FDA Clearance for Proton Beam Radiation Therapy System

Sept. 15, 2025 — Mevion Medical Systems announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the MEVION S250-FIT Proton Beam Radiation Therapy System, marking a significant milestone in expanding access to proton therapy. The MEVION S250-FIT is the first proton therapy system designed to seamlessly fit into a standard radiation therapy vault. By leveraging existing infrastructure, the MEVION S250-FIT system lowers barriers for hospitals and cancer centers to adopt proton therapy, accelerating access and bringing advanced, high-quality proton therapy closer to patients worldwide. “The FDA clearance of the MEVION S250-FIT marks the beginning of a new era in proton therapy. The MEVION S250-FIT system extends Mevion’s leadership in compact proton therapy by combining industry-leading precision, efficiency, and adaptability.