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ViewRay Receives FDA 510(k) Marketing Clearance for Treatment Planning and Delivery Software

Wed, 02/23/2011 - 10:36am
Bio-Medicine.Org

CLEVELAND, Feb. 23, 2011 /PRNewswire/ -- ViewRay™, Inc., a privately held medical device company, has received U.S. FDA marketing clearance for its radiotherapy treatment planning and delivery software. The software is a critical component of the company's new radiation therapy system, which combines simultaneous magnetic resonance imaging and radiotherapy delivery. Now in the late stages of development, the integrated ViewRay system is currently available only as a non–human use research system. The company is working to secure FDA clearance for commercial distribution of the system for clinical use.

"FDA clearance of our software represents a significant milestone in the development of the ViewRay system," said ViewRay President and CEO Gregory M. Ayers, MD, PhD. "In the past year ViewRay has achieved a string of notable successes, in funding and partnerships as well as product development. It's exciting to see such progress with a product we believe will offer an advancement in radiation therapy." The ViewRay system is being designed to provide continuous soft-tissue MRI during cancer treatment so that clinicians can see precisely where the radiation is being delivered.

ViewRay holds the exclusive worldwide license for its combination of MRI and radiotherapy technologies. The company recently secured $20 million in Series C financing intended to move the ViewRay system through the final development and regulatory processes, and toward the goal of commercialization and placement in major medical centers.

About ViewRay

ViewRay, Inc., of Cleveland, Ohio, is a privately held medical device company developing advanced radiation therapy technology for the treatment of cancer. Using MRI-guided radiotherapy, the ViewRay system is being designed to provide continuous soft-tissue imaging during treatment. The system is being developed so that clinicians will be able to see where the actual radiation dose is being delivered

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