Multimodality developer Hitachi Medical Systems America said it has received Food and Drug Administration clearance for commercialization of Hitachi's ProBeat Proton Beam Therapy System in the U.S.
The clearance comes after a staged filing process that began in 2002 and within three months after Hitachi America submitted its final and complete FDA 510(k) filing in December last year, according to the Twinsburg, OH-based company.
The first U.S. ProBeat system is in its final stages of construction at the University of Texas M. D. Anderson Cancer Center Proton Therapy Center in Houston, the firm said. M. D. Anderson plans to begin patient treatments with the technology in May.
By AuntMinnie.com staff writers
March 21, 2006
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