Varian Medical Systems Inc. says it has received U.S. Food and Drug Administration 510(k) clearance for a new suite of features that have been added to the company's On-Board Imager system for Clinac and Trilogy medical linear accelerators (linacs).
Varian's On-Board Imager is an automated system for image-guided radiation therapy (IGRT) and enables clinicians to obtain high-resolution digital images to pinpoint tumor sites, adjust patient positioning and complete a treatment. The FDA-approved capabilities make its On-Board Imager the first linac-based kV x-ray digital imaging system that can synchronize image acquisition with a patient's respiratory cycle and automate "marker matching" for more precise tumor targeting, according to Varian.
The new On-Board Imager features encompass automated tumor marker detection and monitoring and gating for tumor motion.
First cleared by the FDA in February of this year, Varian's On-Board imager has been installed at Karolinska University Hospital in Stockholm, Sweden; Emory University in Atlanta, Georgia; the Henry Ford Health System in Detroit, Michigan; and Memorial Sloan-Kettering Cancer Center in New York. Varian said an additional 46 units are slated for installation at cancer centers worldwide.