FDA Grants 510(k) Clearance to Halcyon IMRT Treatment System

Varian Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Halcyon system, a new device for cancer treatment. Halcyon simplifies and enhances image-guided volumetric-intensity modulated radiotherapy (IMRT).

“We are proud that Halcyon has now received both 510(k) clearance and CE mark,” said Kolleen Kennedy, President of Varian's Oncology Systems Business. “These two clearances are very important milestones in the availability of this new system and in advancing cost-effective cancer care worldwide.”

Key Features

Halcyon is an advanced IMRT system that may be more comfortable for the patient than other IMRT devices, while delivering ease of use for health-care providers, accelerated installation time frames, expedited commissioning, simplified training, and automated treatment. With its streamlined workflow, the system requires 9 steps from the start to the end of treatment, compared to up to more than 30 steps with older technologies. Halcyon can handle the majority of patients with cancer, offering advanced treatments for prostate, breast, head and neck, and many other forms of cancer. 

Halcyon features large touchscreens on both sides of the machine to assist in easy patient setup. For increased patient comfort, Halcyon is up to twice as quiet as other systems, has a low couch height for easy patient access, and soft indirect ambient lighting in the gantry opening. To create a closer connection between patient and therapist during Halcyon treatment, the system includes an integrated couch-mounted camera for the therapist to watch over the patient during treatment, and an integrated noise-cancelling sound system that makes it easy for patients to converse with therapists.

Commentary

“The Halcyon system is not just an iterative improvement,” said James M. Metz, MD, Chairman, Department of Radiation Oncology, University of Pennsylvania Perelman Cancer Center. “The product simplifies treatment delivery while maintaining high-quality plans delivered at significantly increased speed. This allows increased efficiency in the radiation oncology clinic, while delivering exceptional treatments. I expect this will be the new standard for linear accelerators of the future.”

“The technology of radiation oncology is evolving at an increasingly rapid rate,” said Dwight E. Heron, MD, FACRO, FACR, Director of Radiation Services, University of Pittsburgh Medical Center (UPMC) Cancer Center and Director of Oncology, UPMC International. “New technology that integrates advanced adaptive treatment and imaging in a fully integrated form factor will enable innovative and consistent, high-quality state-of-the-art radiation therapy for even the busiest clinics.”

With 510(k) clearance, Varian can begin selling the Halcyon system in the United States. The system requires Eclipse 15.1.1 treatment planning software, which is currently 510(k) pending.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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