News | Proton Therapy | October 07, 2019

ProTom Receives U.S. FDA 510(k) Clearance for Radiance 330 Single Room Proton Therapy System

ProTom International received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Radiance 330 proton therapy system

ProTom International received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Radiance 330 proton therapy system installed at Massachusetts General Hospital (MGH) in Boston, Mass.

The Radiance 330 proton therapy system at MGH is a compact, single room system equipped with an advanced pencil beam scanning system and integrated imaging and control system. The Radiance 330 compact synchrotron can be installed within an interior accelerator vault space of 20′ x 30′ and requires up to 40 percent less radiation shielding.

By using the advanced pencil beam scanning technology, modular designed treatment system and the compact synchrotron particle accelerator, Radiance 330 is a smaller, lighter and cleaner system.

"We are delighted to have received the marketing authorization for the Radiance 330 proton therapy system installed at MGH. 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," said Steve Spotts, Chief Executive Officer and co-founder of ProTom International. "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."

For more information: https://www.protominternational.com

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