FDA clears MEVION S250 Proton Therapy System

Mevion Medical Systems, Inc., a radiation therapy company dedicated to advancing the treatment of cancer, announced today that it has received FDA 510(k) clearance for its MEVION S250 Proton Therapy System. The MEVION S250 is a first-of-its-kind proton therapy system that provides the same precise, non-invasive treatment advantages and capabilities of complex, large, and costly proton therapy systems but with higher patient throughput, a significantly reduced footprint, improved reliability, and lower implementation and operational costs.  The MEVION S250 delivers precise and intense proton beams that physicians can use to treat tumors and lesions or any other condition where radiotherapy is indicated. 

The broad adoption of proton therapy has been greatly limited by the enormous cost, large footprint, and technical complexity of traditional proton therapy systems. Powered by a patented TriNiobium Core™, the MEVION S250 proton therapy system redefines the economics, availability, and the future direction of proton therapy, by bringing the management and operation of proton therapy to levels similar to modern X-ray radiation therapy devices. "Completing this very important milestone is a testament to the maturity of the Mevion organization and its ability to manufacture, install and support a safe and effective product," said Joseph Jachinowski, Chief Executive Officer of Mevion Medical Systems. "We are pleased to receive this clearance from the FDA and now look forward to providing our customers and their patients access to this revolutionary device."

This clearance enables users of the MEVION S250 to immediately treat patients upon completion of their system installation. The first installation of the MEVION S250 will soon be completed at the Kling Center for Proton Therapy at Barnes Jewish Hospital at Washington University in St. Louis, Missouri.

Mevion will be delivering and installing more than a dozen MEVION S250 proton therapy systems worldwide within the next two years, making it one of the leading providers of proton therapy systems. MEVION S250 installations are also underway at Robert Wood Johnson University Hospital in New Jersey and Oklahoma University in Oklahoma. Additional sites in Florida and California will follow these installations.

Earlier this year, the MEVION S250 received CE certification, which gives Mevion the ability to market, sell, import, and install proton therapy systems in the European Union and other regions where the CE Marking is recognized.