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FDA grants 510(k) clearance to Halcyon system for cancer treatment

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The FDA granted 510(k) clearance to the Halcyon treatment system for use with image-guided volumetric intensity modulated radiotherapy, according to the device’s manufacturer.

Halcyon (Varian Medical Systems) is designed to expedite installation timeframes, accelerate commissioning, simplify training for health care providers and automate treatment for patients. The system requires only nine steps from start to finish, compared with more than 30 steps required with older technologies, according to a Varian-issued press release.

“We are proud that Halcyon has now received both 510(k) clearance and CE mark,” Kolleen Kennedy, president of Varian’s oncology systems business, said in the release. “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.”

The system requires Eclipse 15.1.1 treatment planning software (Varian Medical Systems), which is pending 510(k) clearance, according to the press release.