Mevion Medical Systems, a radiation therapy company, has received FDA 510(k) clearance for its MEVION S250 Proton Therapy System.
The MEVION S250, powered by a patented TriNiobium Core, provides the delivers precise and intense proton beams that physicians can use to treat tumors and lesions or any other condition where radiotherapy is indicated.
Mevion Medical Systems chief executive officer Joseph Jachinowski said, "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."
Mevion will carry out the first installation of the proton therapy system at the Kling Center for Proton Therapy at Barnes Jewish Hospital at Washington University in St. Louis, Missouri.
Mevion will deliver more than a dozen MEVION S250 proton therapy systems worldwide within the next two years, with installations already underway at Robert Wood Johnson University Hospital in New Jersey and Oklahoma University in Oklahoma.
CE certificate was awarded to the MEVION S250 system, which enable Mevion to market, sell, import, and install the system in the European Union and other regions where the marking is recognized.