ProTom Radiance 330 proton therapy system bags FDA 510(k) Clearance
ProTom International has been given 510(k) clearance from the US Food and Drug Administration (FDA) for its Radiance 330 proton therapy system installed at the Massachusetts General Hospital (MGH) in Boston.
According to the proton therapy technology manufacturer, the installed Radiance 330 proton therapy system is a compact, single-room system, which features an advanced pencil beam scanning system and integrated imaging and control system.
ProTom says that the Radiance 330 compact synchrotron can be installed within an interior accelerator vault space with dimensions of 20′ x 30′ and would need up to 40% less radiation shielding.
The company claims that Radiance 330 is a smaller, lighter and cleaner system as it utilizes the advanced pencil beam scanning technology and the compact synchrotron particle accelerator.
Radiance 330 proton therapy system. Photo courtesy of ProTom International.
Steve Spotts – CEO and co-founder of ProTom International said: “The receipt of 510(k) clearance is the final culmination of a thorough and rigorous FDA review of the safety and effectiveness of our compact proton therapy solution.
“This achievement accelerates ProTom’s single and relentless mission to place this highly sophisticated and targeted cancer-fighting tool within reach of many more physicians.
“Our team couldn’t be more proud of reaching this milestone and will continue our work to advance the delivery of proton therapy while driving down the cost of this much-needed technology.”