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Elekta obtains FDA 510(k) clearance for Monaco 5 treatment planning system

Sweden-based Elekta has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the latest version of its Monaco treatment planning system, Monaco 5.

Elekta’s Monaco now supports the full spectrum of radiotherapy techniques, including volumetric modulated arc therapy (VMAT), intensity-modulated radiation therapy (IMRT) and 3D conformal radiation therapy.

This system is especially well equipped for sophisticated stereotactic therapies, such as stereotactic radiation therapy and stereotactic radiosurgery, with added planning support for specialized beam shaping solutions, including circular cones.

Monaco 5 incorporates Monte Carlo dose engine, which is considered as the gold standard for calculating radiation dose.

The Union Hospital’s HUX Cancer Center (Terre Haute, Indiana) clinicians have been evaluating the non-clinical alpha version of Monaco 5 for several months.

Elekta Software executive vice president Todd Powell noted Monaco 5 consolidates the best of the company’s treatment planning solutions into one system, increasing confidence and clinical versatility for the radiation oncology team.

"Its new system architecture allows advanced treatment plans to be created faster than ever," Powell added.

Monaco 5 treatment planning system is now available for purchase and use in the US.