FDAnews Device Daily Bulletin

FDA APPROVES HITACHI PROTON BEAM THERAPY SYSTEM

March 22, 2006
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The FDA has granted 510(K) clearance to Hitachi America's Probeat proton beam therapy system for treating tumors, the company reported.

Currently in its final stages of construction at the University of Texas M.D. Anderson Cancer Center, the Probeat system is designed to produce and deliver a therapeutic proton beam for treating tumors and other conditions susceptible to treatment by radiation.

"Proton therapy was a natural 'next step' for the Division of Radiation Oncology at M.D. Anderson which has a long history of moving the discipline forward," said James Cox, professor and head of the Division of Radiaion Oncology. "This proton therapy center, one of only three such hospital-based centers in the nation, has been innovative on so many levels from the business model to the technology itself and we are proud to call Hitachi a partner," he said.