CMS Inc. has completed internal and external validation testing for its new Monaco IMRT planning system. The company has proceeded with applying to the Food and Drug Administration for 510(k) clearance to distribute Monaco in the United States. The software has already obtained its CE mark and the first customer installations in Europe are being scheduled for this summer.
Monaco uses a set of tools to make the radiotherapy planning process easier, more straightforward, and clinically reliable. The system is designed to improve repetitive trial-and-error methods for determining the optimal plan; multiple variables to manage the planning process; and a lack of control over the “black box” optimization process.
“We are enthusiastic about the pending review and approval to distribute Monaco in the U.S. market,” said Andrew C. Cowen, president and CEO of CMS. “This will be the first Monte Carlo-based IMRT planning solution commercially available in the world, and one that further incorporates a number of new and exciting concepts for IMRT planning. Monaco shows great promise to enhance efficiency and accuracy and the quality of care our clinical partners can provide to patients.”