Accuray has secured Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Radixact treatment delivery system, Accuray Precision treatment planning system and iDMS data management system.
Unitedly, the treatment delivery system and software solutions will allow clinicians to offer precise treatment for a range of cancer patients, including those undergoing retreatment.
Last August, the company also secured CE mark approval for Radixact system to sell in the European market. In June same year, the company also secured FDA 510(k) clearance for the Radixact platform.
The company is currently selling Radixact platform in Japan, certain markets in the European Union and the US.
Radixact is an advanced radiation therapy device, which features linear accelerator, low-dose fan beam MVCT imaging and helical treatment mode, which will allow clinicians to deliver accurate and individualized dose distributions to any tumor.
The fully-integrated and simplified adaptive treatment planning solution allows clinicians to regularly adjust treatment plans during the course of treatment to know changes in tumor size, shape and location, enabling to increase treatment precision.
Accuray Japan general manager and president Juki Hozumi said: "The Accuray team strives to provide our customers with innovative products that enhance the quality of patient care. With the introduction of the Radixact System, we are demonstrating significant progress in fulfilling on this promise.
“This new, mainstream System enables clinicians to deliver the highly sculpted doses for precise, customized treatments the previous TomoTherapy platform was known for, faster, enabling the treatment of more patients every day.”
Accuray president and CEO Joshua Levine said: "The approval of the Radixact System represents a key milestone in our strategic growth plans for the Japanese market.”