ViewRay Announces FDA Clearance for Advancements in MRI and Functional Imaging Technologies for MRIdian MRI-Guided Radiation Therapy System


ViewRay, Inc. announced that the company received 510(k) clearance from the U.S. FDA to market new soft tissue visualization capabilities for its MRIdian system. The new upgradable capabilities enhance the industry-leading features of MRIdian’s SmartVISION MRI, including:

Expanded high-definition visualization and enhanced contrast between different tissues, to assist clinicians with tissue visualization and beam contouring
The potential to aid in the assessment and prediction of tumor response to radiation therapy is enabled by “DWI”, our diffusion weighted imaging feature which tracks treatment progress by distinguishing between tumor and normal tissues.

Faster, brighter, more detailed anatomical planar imaging to strike tumors with greater precision and accuracy through our proprietary technology, which allows for a 2X increase in MR imaging speed (to 8 frames per second), a 2X increase in image resolution, and a 2X improvement in MR signal-to-noise ratio (SNR)

Potential reduction in treatment delivery time through enhanced MLC speed

“Today we announce another significant step forward in our drive to better treat cancer patients and further differentiate MRIdian in the marketplace”, said James Dempsey, Ph.D., Founder and Chief Scientific Officer of ViewRay. “Our customers are seeking significant improvements on imaging speed, resolution and brightness. They also demand that we avoid artifacts and distortions that have historically and consistently plagued the field. We believe these innovations hit the mark. We will continue to advance the field of MR Guided Radiation Therapy and expand the application of the MRIdian system.”

MRIdian’s SmartVISION provides high-definition, diagnostic-quality MR imaging. SmartVISION was designed to maintain high-fidelity beam delivery, while mitigating the risks of skin toxicities, as well as trapped or distorted dose. MRIdian’s SmartADAPT helps allow clinicians to generate daily MR setup scans in seconds and leverage high-contrast anatomical detail to rapidly reshape dose delivery based on the current position of both the tumor and adjacent critical structures – all while the patient is in the treatment position. MRIdian’s SmartTARGET visualizes the tumor’s edges and surrounding organ position in real-time using a non-ionizing, streaming video perspective. When tumors or organs-at-risk change shape or position, SmartTARGET instantly reacts, automatically controlling beam delivery.

About ViewRay®
ViewRay, Inc. , designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian is built upon a proprietary high-definition MR imaging system designed from the ground up to address the unique challenges and clinical workflow for advanced radiation oncology. Unlike MR systems used in diagnostic radiology, MRIdian’s high-definition MR was purpose-built to address specific challenges, including beam distortion, skin toxicity, and other concerns that potentially may arise when high magnetic fields interact with radiation beams.