FDA OKs Mevion S250-FIT Proton Therapy System

Mevion Medical Systems has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Mevion S250-FIT proton beam therapy radiation system.

Mevion S250-FIT, according to the company, is the first and only proton therapy system designed to seamlessly fit in a standard radiation therapy vault. It leverages existing infrastructure to lower barriers for hospitals and cancer centers to adopt proton therapy.

It’s currently being installed at Stanford Health Care and BayCare Health System, with further installations beginning at Atlantic Health System and the University of Nebraska Medical Center. This reaffirms Mevion’s role as a trusted partner of leading cancer centers.

Mevion S250-FIT grows the company’s leadership in compact proton therapy. It builds on the company’s Hyperscan pencil beam scanning platform and introduces DirectArc proton arc therapy. The FIT system is also FLASH research ready so cancer centers can gain advanced capabilities while remaining ready for future innovations.

“The FDA clearance of the MEVION S250-FIT marks the beginning of a new era in proton therapy,” said Tina Yu, president and CEO of Mevion Medical Systems. “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. 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.”