US-based Mevion Medical Systems has won FDA 510(k) clearance for its Mevion S250 proton therapy system.
The Mevion S250 emits proton beams that can be used by physicians to treat tumours and lesions or any other condition where radiotherapy is indicated.
Mevion Medical Systems CEO, Joseph Jachinowski, said: "We are pleased to receive this clearance from the FDA and now look forward to providing our customers, and their patients, with access to this revolutionary device."
The Mevion S250 proton therapy system is designed to preserve all treatment benefits of traditional proton therapy systems, while removing the obstacles of size, cost and complexity.
The new proton therapy system facilitates higher patient throughput, improved reliability and lower implementation and operational costs, according to the company.
By leveraging patented TriNiobium Core technology, the company claims that the Mevion S250 proton therapy system can redefine the economics, availability and future direction of proton therapy.
Barnes Jewish Hospital at Washington University in St. Louis, Missouri, will soon become the first to install Mevion S250 at the Kling Center for Proton Therapy.
The device has also gained CE certification, which enables Mevion to market, sell, import and install proton therapy systems in the EU and other regions where the CE Mark is recognised.
Mevion Medical Systems is a radiation therapy company that develops proton therapy systems to provide safe and effective solutions by transforming advances in medical technology and science into practical clinical reality.