FDA Clears New Image-Guided Treatment System

A new radiotherapy system that offers advanced treatments for breast, prostate, and head and neck cancers, among many others, has received US FDA 510(k) clearance.

The Image-Guided Volumetric Intensity Modulated Radiotherapy (IMRT) already received the European CE mark. The highly automated system features a new streamlined workflow with less than a third of the workflow steps of systems using older technologies.


The Halcyon radiotherapy system was developed by Varian Medical Systems (Palo Alto, CA, USA), one of the largest manufacturers of medical devices and software for the treatment and management of cancers. The Eclipse 15.1.1 treatment planning software, that is required to operate the Halcyon system, is currently pending US FDA 510(k) approval.

The Halcyon radiotherapy system can be installed and commissioned faster, and requires less training than previous systems. The system has large touch screens on both sides for ease of access, is nearly twice as quiet as older systems, and has soft indirect ambient lighting in the opening of the gantry for patient comfort. The system has a low couch height to facilitate patient access, an integrated couch-mounted camera to allow clinicians to monitor the patient during treatment, and an integrated noise-cancelling sound system for communicating with the patient.

President of Varian Oncology Systems, Kolleen Kennedy, said, "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."