Varian Receives FDA 510(k) Clearance for Halcyon and Ethos Radiotherapy Systems Featuring HyperSight Imaging Solution and Announces First Patient Treatment

Achieves CE Mark for Halcyon and Ethos Radiotherapy Systems Featuring HyperSight

Excerpt from the Press Release:

PALO ALTO, Calif., Feb. 2, 2023 /PRNewswire/ — Varian, a Siemens Healthineers company, announced today that it 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 tumors, and HyperSight now enables them to be used for replanning and adaptation to patient and tumor 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 tumors that move with breathing — including lung, liver, and left breast tumors — 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.

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