FDA Clears ProTom's Proton Therapy System

Samara Rosenfeld
OCTOBER 07, 2019
proton therapy
Photo/Thumb have been modified. Courtesy of ProTom International Holding Corporation. 

The U.S. Food and Drug Administration (FDA) today announced it granted 510(k) clearance to ProTom International Holding Corporation for its proton therapy system which could improve outcomes for patients with cancer.

The Radiance 330 proton therapy system is a compact, single room system equipped with a pencil beam scanning system and integrated imaging and control system.

Pencil beam scanning is said to be the most advanced type of proton therapy and is used to treat complex cancers with extreme precision. This method uses a tumor’s locations, shape and size to create a customized pattern of protons to precisely treat the tumor and avoid nearby healthy tissue.

Using pencil beam scanning does not require patient-specific devices, which could eliminate treatment delays, reduce treatment time and costs, increase flexibility in treatment delivery and reduce exposure to secondary radiation.

Through this method, the Radiance 330 proton therapy system reduces unwanted side effects and could improve long-term patient outcomes and quality of life, ProTom said.

The system supports single, multi-room and expandable configurations and its beam transport system guides the proton beam from the synchrotron to the treatment room.

“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, CEO 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.”

The system is currently installed at Massachusetts General Hospital in Boston.

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