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Sumitomo obtains FDA 510(k) clearance for proton therapy system

Sumitomo Heavy Industries has obtained the US Food and Drug Administration (FDA) 510(k) clearance of its Proton Therapy System, a form of radiation therapy, which employs proton beams to kill cancer cells with better dose distribution in comparison with conventional x-rays.

It is reportedly the first 510(k) cleared medical device for Sumitomo.

The system has a 230MeV proton accelerator (cyclotron) and 360 degree single or multiple rotating gantries with a proven and robust design.

Proton beam features a unique characteristic called Bragg Peak, which is especially advantageous for cancers around critical organ structures and pediatric cancers.

More absorption dose is delivered as the proton loses its energy; consequently, the maximum dose is deposited just before the beam stops, and there is no radiation dose to normal cells behind the target tumor volume.

Sumitomo Heavy Industries vice president Yukio Kumata said with 510(k) clearance, the company has received a ticket for admission to the US market, but this is just the beginning of establishing a long term trusting relationship with the equipment users such as hospitals, doctors and cancer patients.

"The Sumitomo Proton Therapy System has an excellent track record and keeps evolving in performance, function, and reliability with solid technological experiences," Kumata added.

"We are hoping the Sumitomo Proton Therapy System will be used to save many cancer patients in the U.S."