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Varian receives FDA clearance, CE Mark for Halcyon and Ethos radiotherapy systems

Varian, a Siemens Healthineers company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as CE mark, for Halcyon and Ethos radiotherapy systems featuring Varian’s HyperSight imaging solution. On February 1, a cancer patient at Penn Medicine became the first person in the world to be treated on a Halcyon system equipped with HyperSight.

HyperSight enables clinicians to capture high-quality images of patients during their daily radiation treatments. These images are used for daily localization of patient tumours, and HyperSight now enables them to be used for replanning and adaptation to patient and tumour changes. HyperSight’s cone-beam computed tomography (CBCT) technology delivers larger images with better contrast, and is 10 times faster than conventional linear accelerator-based imaging systems, saving time for patients and creating the potential to significantly enhance the patient experience.

Traditional CBCT imaging can take up to 60 seconds and may require patients with tumours that move with breathing – including lung, liver, and left breast tumours – to hold their breath several times to acquire a full, clear image. HyperSight can acquire images in six seconds, potentially minimizing patient discomfort and anxiety and contributing to clearer images due to reduction of motion related image blurring.

The quantitative information about patient anatomy (Hounsfield Units) contained within HyperSight images allows, for the first time, for radiation dose distributions to be calculated directly on CBCT images. This calculation previously required a patient to make an additional trip to a separate CT scanner used for treatment simu-
lation and planning. With HyperSight, this calculation can be performed directly on the linac-based CBCT image during the normal course of treatment. As a result, this technology may help adapt treatment to adjust to anatomical changes to the tumour and surrounding organs, which can change from day to day during treatment.

“Varian has long been focused on pioneering innovations that can enhance the radiotherapy experience and outcomes for both patients and cancer care teams. Becoming a Siemens Healthineers company has given us an opportunity to sharpen and accelerate these efforts, with a focus on connecting the power of imaging inside and outside the treatment room,” said Kevin O’Reilly, President of Radiation Oncology Solutions at Varian. “HyperSight reflects the power of our expanded view of the patient journey and robust imaging technology.”

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  • National Healthcare CFO Summit
  • Marcusevans 36th national healthcare