Hitachi (NYSE:HIT) said this week it won FDA 510(k) clearance for its Real Time Image Gating System designed for use with its proton beam therapy systems.
Real Time Image Gating Proton Beam Therapy is designed to track and irradiate tumors in motion, using a 2mm diameter gold marker close to the tumor to establish its location as a reference via computed tomography.
A dual-axis, orthogonal X-ray system is then used with pattern recognition software to identify the spatial location of the marker, and irradiation during treatment is performed only when the gold marker moves to within millimeters of the planned irradiation location.
Development of the technology was sponsored in part by a grant from the Funding Program for World-Leading Innovative R&D on Science and Technology in 2010, sponsored by the Japanese Government. The grant was awarded to a joint project between Hitachi and Hokkaido University.
Hitachi won clearance for the RGPT technology from Japan’s Pharmaceuticals Medical Device Administration in 2014.
“Hokkaido University has been developing motion tracking technology in the field of X-ray therapy. By combining this technology with Spot Scanning technology, the accurate irradiation of tumors, including those attached to large organs in motion which are difficult to irradiate with X-rays, will be possible and will lead to greater adaptation. I am very pleased that this innovation for highly precise irradiation will become broadly available around the world,” Hokkaido Univeristy Hospital research group director Dr. Hiroki Shirato said in a prepared statement.
Hitachi said that with the clearance, it is moving forward with plans to install RGPT systems at facilities under construction in the US.
