ProTom International, Inc. Receives FDA 510(k) Clearance for its Radiance 330® Proton Therapy System

FLOWER MOUND, Texas--()--ProTom International, Inc., the developer and manufacturer of a technologically advanced proton beam radiation therapy system, announced today it has received 510(k) clearance for its Radiance 330 Proton Therapy System. The 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 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.

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.”

About ProTom International, Inc.

ProTom is a privately-held company, developing innovative and affordable solutions for proton radiation therapy. ProTom has offices in Flower Mound, Texas and Wakefield, Massachusetts. Its Engineering, Physics, Clinical, Operational and IT leadership experience collectively spans 150 years in healthcare, with more than 75 years of combined experience in proton therapy. Developing and delivering highly sophisticated proton therapy technology is not only what we do, it is all we do. Our medical device operations are headquartered in the USA — from which all of our design, manufacturing, and service divisions are currently managed and operated. To find out more about the future of proton therapy, visit us at www.protominternational.com.

Contacts

ProTom International, Inc.
Thomas Carman, 972-410-3551 x2008
SVP Sales and Development
tcarman@protominternational.com

Radiance 330 Treatment Room (Photo: Business Wire)

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Release Summary

ProTom International, developer and manufacturer of a technologically advanced proton therapy system, announced today it has received 510(k) clearance for its Radiance 330 Proton Therapy System.

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Contacts

ProTom International, Inc.
Thomas Carman, 972-410-3551 x2008
SVP Sales and Development
tcarman@protominternational.com