FDA Clears the MEVION S250-FIT Proton Therapy System

Mevion Medical Systems has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for the MEVION S250-FIT Proton Beam Radiation Therapy System, reportedly the first and only such system that seamlessly fits 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, according to the company.

The MEVION S250-FIT is currently under installation at Stanford Health Care and BayCare Health System, with additional installations beginning at Atlantic Health System and the University of Nebraska Medical Center.

“The FDA clearance of the MEVION S250-FIT marks the beginning of a new era in proton therapy. For more than two decades, Mevion has redefined proton therapy through audacious innovation—from pioneering the world’s first compact, single-room system to now enabling proton therapy to fit into existing radiation therapy vaults, expanding access for patients worldwide,” Mevion Medical President/CEO Tina Yu said. “I am proud of the Mevion team and our partners at Leo Cancer Care for making this achievement possible and look forward to the impact of this innovation as centers like Stanford bring it to patients.”

The MEVION S250-FIT system combines precision, efficiency, and adaptability. Building on Mevion’s HYPERSCAN pencil beam scanning platform and introducing DirectArc proton arc therapy, the FIT system is also FLASH research ready, ensuring cancer centers gain advanced capabilities while staying ready for future innovations.

Mevion Medical Systems develops compact proton therapy and is dedicated to advancing accessibility to high-quality cancer care. Founded in 2004 by representative from Mass General and MIT, Mevion pioneered the world’s first single-room proton therapy system. Cancer centers worldwide use Mevion’s systems—including the MEVION S250i and MEVION S250-FIT with HYPERSCAN pencil beam scanning and DirectArc proton arc therapy—to deliver precise care. The company’s headquarters and manufacturing operations are located in Littleton, Mass.; the firm also has a presence in Europe and Asia.