Mevion Medical Systems has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Mevion S250i proton therapy system with the company's Hyperscan pencil-beam scanning technology.
The Hyperscan technology incorporates faster energy layer switching, optimized spot sizes, and Mevion's Adaptive Aperture proton collimation system, which is a multileaf collimator capable of multilayer conformal field delivery. It provides up to a three times sharper lateral penumbra, which can reduce dose uncertainty at the edge of the tumor, according to Mevion.
The first Mevion S250i system was installed at MedStar Georgetown University Hospital in Washington, DC, and is currently undergoing final testing. Upon 510(k) clearance, the center will be the first in the world to treat patients using the Hyperscan technology, the firm said. The unit will also be the first and only proton therapy system in the Washington, DC, metropolitan area.
