Sumitomo Heavy Industries, Ltd. receives FDA 510(k) clearance
August 31, 2016
Sumitomo Heavy Industries, Ltd. (TSE:6302) recently received FDA 510(k) clearance for the pencil beam scanning of its Proton Therapy System. Pencil beam scanning is one of the active beam delivery methods in particle therapy. It has great potential to provide better dose distribution than a passive method such as scattering technique. Sumitomo employs continuous line scanning (“Line scanning”) where the beam spot is continuously moving in a tumor. Current mainstream use of pencil beam scanning is discrete spot scanning which employs a repetitive step-and-shoot process. Line scanning has no dead-time, which is inherent in the discrete spot scanning, and a significantly shorter scanning time is feasible in comparison with discrete spot scanning.
Line scanning combined with the Sumitomo Proton Therapy cyclotrons’ capability of delivering a continuous, strong beam current and a stable beam with very high dose-rates, enables clinicians to shorten irradiation times further.
This is a landmark development for a commercially available proton system and a major step for fast scanning. Radiation oncologists increasingly prefer the pencil beam scanning for intensity modulated proton therapy or IMPT, and Line scanning is expected to have more popularity in IMPT.
Sumitomo was one of the first companies to develop proton therapy systems for cancer treatment and delivered its first system in 1997 to the National Cancer Center Hospital East, Kashiwa, Japan. Since then, Sumitomo has delivered proton systems in Japan, Taiwan and Korea.
“Line scanning has already been implemented for our Asian customers, and with this clearance, we are very excited to be able to offer this advanced technique for the U.S. market. We believe Line scanning will greatly enhance the patient experience as the treatment times can be significantly reduced. It will facilitate irradiation of tumors especially in moving organs, improving dose distribution. Beyond pencil beam scanning, Sumitomo will continue to further the technology of particle therapy,” said Kazuto Kaneshige, Senior Vice President of Sumitomo Heavy Industries, Ltd.
Sumitomo Heavy Industries, Ltd. (http://www.global-shi.com/index.html)
Sumitomo Heavy Industries, Ltd. (TSE:6302) is a technology-oriented manufacturer of medical and industrial machinery based in Tokyo, Japan. Its accelerator technology is widely used in the semiconductor industry and nuclear physics research sector as well as in medical applications. Fiscal Year 2015 annual sales were $6.2B. Sumitomo Heavy Industries employs approximately 18,000 individuals worldwide.