Elekta Synergy receives FDA 510(k)

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The FDA this week granted 510(k) pre-market clearance to Elekta AB's Elekta Synergy system.

 Elekta Synergy uses x-ray volume imaging technology integrated directly onto the treatment system itself. The technique is designed for routine pre-treatment imaging of a tumor immediately prior to treatment, decreasing the risk that a tumor or internal organs will change position. Since a patient does not have to be moved from an imaging device -- such as an MRI or CT scanner -- to the radiotherapy treatment machine, errors from patient re-setup can be eliminated.

 Elekta Synergy has been available in Europe since July, when the system received the CE mark.

 Elekta says that clinical research has found that by combining an x-ray volume imaging system and radiotherapy equipment, such as a medical accelerator, to provide real-time images of the tumor during treatment, the image quality and treatment accuracy is significantly improved.