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FDA Clears Varian Medical's Two Products - Quick Facts

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1/24/2013 8:29 AM ET

Varian Medical Systems (VAR: Quote) Thursday said it has received an FDA 510(k) clearance for the latest version of its Vitesse real time planning for HDR brachytherapy. This is used to plan and perform high-dose-rate or HDR, ultrasound-guided brachytherapy treatments for prostate cancer.

Tim Clark, marketing manager for Varian BrachyTherapy, said, "This version of Vitesse reduces the number and complexity of steps involved in planning and completing a treatment. It eliminates the need for a data transfer to another software program, and avoids moving the patient to a CT scanner for images in the middle of the procedure.''

According to him, most clinicians will see a reduction in the amount of time needed to complete these treatments, often by as much as an hour and a half.

Separately, the company said the regulator also cleared its Edge radiosurgery suite, a new dedicated system for performing advanced radiosurgery using innovative real-time tumor tracking and motion management technologies.

According to the company, this enables fast, accurate delivery of stereotactic radiosurgery for treating lesions, tumors, and conditions anywhere in the body where radiotherapy is indicated, including tumors of the lung, prostate, spine and brain.

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by RTT Staff Writer

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