Healthcare Industry News:  IMRT 

Devices Oncology FDA

 News Release - October 16, 2007

CMS Receives FDA 510(k) Clearance for Monaco(TM), The Next Generation in IMRT Planning

Monaco Represents a New and Advanced Approach to IMRT Featuring a Unique and Innovative Set of Clinical Tools to Make the Planning Process Easier, More Straight Forward, and Clinically Reliable

ST. LOUIS--(HSMN NewsFeed)--CMS, the worldwide market leader in radiation treatment planning and workflow management solutions, has received FDA 510(k) clearance for Monaco, its next-generation IMRT planning platform. This clearance allows CMS to begin distributing Monaco for clinical use in the United States. CMS previously announced the release of Monaco 1.0 in July and the first clinical implementations have already been completed in Europe and Australia.

Monaco was developed in collaboration with Markus Alber, Ph. D. and colleagues at the University of Tubingen in Germany. Monaco features innovative biological cost functions with multi-criterial constrained optimization, a powerful leaf sequencer, and a robust Monte Carlo dose calculation algorithm, and represents the most advanced IMRT solution on the market. Monaco is fully integrated with CMS's Focal platform, providing seamless connectivity and integration with Focal's advanced fusion, contouring, simulation and plan review capabilities, and represents the state-of-the-art for IMRT planning.

"We are pleased to receive clearance to distribute Monaco in the U.S. market," said Andrew C. Cowen, President and Chief Executive Officer of CMS. "Monaco shows great promise in the efficiency and accuracy of radiation treatment planning, and can positively impact the quality of care our clinical partners can provide to their patients."

"Monaco comprises many new concepts. Over the years, CMS has proven to be a reliable and competent partner in developing these concepts into a highly useable clinical tool and a solid platform for future technologies," said Markus Alber, Ph.D. "The ultimate goal of research should be its application in the clinic, and Monaco represents much more than a faithful translation of our work into a product thanks to the consistent and positive experience of CMS with treatment planning software."

CMS is a worldwide leader in the development and support of radiation treatment planning and workflow management solutions. With treatment planning systems installed in more than 1,500 sites worldwide, CMS is a global resource to the radiation oncology community. A privately held corporation, CMS employs 290 professionals in its headquarters located in St. Louis, MO and regional offices in Tampa, Florida; Freiburg, Germany; Tokyo, Japan; Sydney, Australia; and Shanghai, China.

Forward-Looking Statements: Statements contained in this release, which are not historical facts, may be considered "forward-looking statements" under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on current expectations and the current economic environment. We caution the reader that such forward-looking statements are not guarantees of future performance. Unknown risk, uncertainties as well as other uncontrollable or unknown factors could cause actual results to materially differ from the results, performance or expectations expressed or implied by such forward-looking statements.

Source: CMS, Inc

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