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Home » Varian wins U.S., European clearance for radiotherapy systems

Varian wins U.S., European clearance for radiotherapy systems

February 2, 2023 By Sean Whooley

Varian Halcyon radiotherapy system Siemens Healthineers HyperSight Ethos
The Halcyon radiotherapy system. [Image from the Varian website]
Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance and CE mark for its Halcyon and Ethos systems.

Both radiotherapy systems feature Varian’s HyperSight imaging solution. HyperSight enables clinicians to capture high-quality images of patients during their daily radiation treatments. The images help in the daily localization of patient tumors and their uses include replanning and adaptation to patient and tumor changes.

HyperSight uses cone-beam computed tomography (CBCT) technology. This delivers larger images with better contrast. Varian said in a news release that this method is 10 times faster than conventional linear accelerator-based imaging systems. Traditional CBCT imaging may take up to 60 seconds and require patients to hold their breath. HyperSight acquires images in six seconds, potentially minimizing patient discomfort and anxiety while offering clearer images.

Varian said a cancer patient at Penn Medicine became the first person in the world treated with a Halcyon system equipped with HyperSight. The treatment took place yesterday, Feb. 1.

HyperSight also allows for the calculation of radiation dose distributions directly on CBCT images. This may help adapt treatment to adjust to anatomical changes to the tumor and surrounding organs, Varian said. Kevin O’Reilly, president of radiation oncology solutions at Varian, credited the innovation to its acquisition by Siemens Healthineers. He said it allowed the company to “sharpen and accelerate” its efforts.

“HyperSight reflects the power of our expanded view of the patient journey and robust imaging technology,” O’Reilly said. “We look forward to working with our clinical partners and the broader radiotherapy community to drive adoption and further advancement of this technology, as we continue our work to transform the patient pathway and deliver on our mission to create a world without fear of cancer.”

Siemens Healthineers acquired Varian in April 2021 for $16.4 billion.

Filed Under: 510(k), Food & Drug Administration (FDA), Imaging, Oncology, Radiosurgery/Radiation therapy, Regulatory/Compliance Tagged With: CE Mark, FDA, Siemens Healthineers, Varian

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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