FDA Clears ProTom’s Radiance 330® Proton Therapy System

Proton Beam Therapy specialist company ProTom International, Inc. has announced that it has received U.S. FDA 510(k) clearance for its Radiance 330 Proton Therapy System.


ProTom is a privately-held company, developing innovative and affordable solutions for proton radiation therapy. Its Radiance 330 is a compact, modular and more affordable proton beam delivery system for the treatment of patients with cancer. The system delivers extremely focused, conformal, scanned proton beams that destroy tumors while sparing nearby healthy tissue and anatomical structures.

The company claims its system’s modular design easily accommodates the buyer’s preferences for 3-D imaging solutions and treatment planning software through industry-standard interfaces. The compact accelerator can be installed within an interior vault space of approximately 20’ x 30’ and requires up to 40% less radiation shielding than many other systems on the market today.

The Radiance 330 can be configured using its single, energy-efficient synchrotron to operate a single or multiple treatment room facility; treatment rooms can be equipped with isocentric gantries or as fixed-beam lines with one or more ports.

Company comments

Steve Spotts, Chief Executive Officer and co-founder of ProTom International, commented, “The receipt of 510(k) clearance is the final culmination of a thorough and rigorous FDA review of the safety and effectiveness of the Radiance 330. This achievement accelerates our team’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.”

Source: ProTom International, Inc., Business Wire

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