MRIdian Receives China NMPA Approval

By News Release


The MRIdian MRI-Guided Radiation Therapy System from ViewRay has received approval from the Chinese regulatory authority National Medical Products Administration (NMPA). This approval expands MRIdian's global reach and offers cancer patients a new radiation therapy option, MRIdian Stereotactic MRI-Guided Adaptive Radiotherapy (SMART), allowing treatment that integrates diagnostic-quality MR imaging, on-table adaptive replanning, and continuous, real-time, soft tissue tracking and automated beam gating.

According to 2020 GLOBOCAN data, there are about 4.6 million new cases of cancer diagnosed annually in China. The country aims to increase the five-year survival rate of cancer patients by 15% as outlined in its Healthy China 2030 initiative.

"With the increasing burden of cancer prevalence in China, we are excited to bring the benefits of MRIdian SMART to these patients," said Paul Ziegler, ViewRay Chief Commercial Officer. "The availability of more treatment options, excellent treatment outcomes, reduced toxicity, and improved quality of life is an important advance for this market. The China NMPA approval not only supports our global expansion but also our goal of changing the paradigm of care in radiation oncology."

The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target, while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.