Varian Medical wins FDA nod for Halcyon radiotherapy cancer treatment system

Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance for its Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system.
The Palo Alto, Calif.-based company said its Halcyon IMRT system features improvements that make it more comfortable for patients and streamline operator’s workflow, only requiring 9 steps from start to treatment, down from 30 steps in legacy machines.
“We are proud that Halcyon has now received both 510(k) clearance and CE mark. With its human-centered and user-friendly design, Halcyon is engineered to revolutionize clinical workflow. These two clearances are very important milestones in the availability of this new system and advancing cost-effective cancer care worldwide,” Varian oncology systems biz prez Kolleen Kennedy said in a press release.
Varian Medical said the device is designed to handle “the majority” of cancer patients, including individuals with prostate, breast, head & neck and other forms of cancer. The system requires the company’s Eclipse 15.1.1 treatment planning software, which is currently pending 510(k) approval.
In May, Varian Medical said it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its ProBeam system designed for proton therapy.


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