LITTLETON, Mass.– Mevion Medical Systems today 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 major milestone in expanding access to advanced cancer care.
The MEVION S250-FIT is the first and only proton therapy system designed to fit seamlessly into a standard linear accelerator (LINAC) vault. By leveraging existing radiation therapy infrastructure, the system reduces barriers for hospitals and cancer centers to adopt proton therapy, broadening patient access to high-quality treatment options.
The new system is currently being installed at Stanford Health Care and BayCare Health System, with additional installations beginning soon at Atlantic Health System and the University of Nebraska Medical Center. Mevion said the early adoption by these leading institutions demonstrates the growing momentum behind the S250-FIT as a future-ready, cost-efficient solution that strengthens its role as a trusted partner to top cancer centers worldwide.
“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,” said Tina Yu, CEO and President of Mevion Medical Systems. “I am incredibly 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 extends the company’s leadership in compact proton therapy by combining precision, efficiency, and adaptability. It builds on Mevion’s HYPERSCAN pencil beam scanning platform and introduces DirectArc proton arc therapy, while also being FLASH research ready, ensuring cancer centers benefit from cutting-edge capabilities today while preparing for future advances.
