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Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA Clears Sumitomo’s Proton Therapy Device

Dec. 5, 2013

The FDA has granted Japan’s Sumitomo Heavy Industries its first 510(k) clearance for a 23 MeV cyclotron proton beam radiation therapy device that targets cancer cells.

The devicemaker touts the compact system, operable with a single button, as having better dose distribution than other radiation methods. The system also allows for moderation of the size of the proton beam according to the size of the tumor.

Sumitomo provided its first proton therapy system to a hospital in Japan in 1997. The company also makes a positron emission tomography system. — Lena Freund

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