Mevion Secures FDA Clearance for MEVION S250-FIT Proton Therapy System
Mevion Medical Systems announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the MEVION S250-FIT proton beam therapy system. The system is the first designed to integrate into a standard linear accelerator vault, a development aimed at lowering barriers to adoption and broadening patient access to proton therapy.
The S250-FIT is already being installed at Stanford Health Care and BayCare Health System, with additional deployments underway at Atlantic Health System and the University of Nebraska Medical Center. According to the company, these installations signal strong interest among leading cancer centers in adopting the new platform.
Building on Mevion’s earlier compact single-room designs, the system incorporates the company’s HYPERSCAN pencil beam scanning platform and introduces DirectArc proton arc therapy. It is also configured to support FLASH research, allowing institutions to participate in next-generation treatment development while addressing current patient needs.
Mevion highlighted the clearance as a continuation of its efforts to make proton therapy more accessible by reducing infrastructure requirements. The company plans to showcase the MEVION S250-FIT at the upcoming ASTRO 2025 Annual Meeting in San Francisco.
