Varian Receives FDA 510(k) Clearance for TrueBeam and Edge Radiotherapy Systems Featuring HyperSight Imaging Solution | Varian

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Varian Receives FDA 510(k) Clearance for TrueBeam and Edge Radiotherapy Systems Featuring HyperSight Imaging Solution

  • HyperSight is designed to enhance accuracy in delivering radiotherapy treatments, with the goal of effective protection of healthy tissues
  • The addition of HyperSight extends adaptive planning capabilities across Varian treatment platforms
  • HyperSight offers clinicians greater flexibility to streamline workflows and personalize care for patients

PALO ALTO, Calif., Feb. 29, 2024 /PRNewswire/ -- Varian, a Siemens Healthineers company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for TrueBeam and Edge radiotherapy systems featuring HyperSight imaging solution. By extending the groundbreaking HyperSight imaging solution optional feature to the TrueBeam and Edge systems, Varian continues to revolutionize imaging inside the radiotherapy treatment room and adds new capabilities and workflows across the entire suite of linear accelerators. HyperSight empowers clinicians to accurately tailor treatments to each individual patient with the goal of improving patient outcomes.

HyperSight imaging allows clinicians to acquire high-quality images during a patient's daily course of radiation treatments. The enhanced image quality is designed to improve the ability to target tumor volumes more precisely and spare healthy tissue for patients receiving radiation therapy treatments. With the addition of HyperSight, linear accelerators across the Varian portfolio can now produce images that deliver the Hounsfield Unit (HU) accuracy necessary for treatment planning directly on the acquired conebeam CT (CBCT) images. As a result, this technology can be used for offline adaptive planning to adjust for anatomical changes to the tumor and surrounding organs over the course of treatment without the need for an additional trip to a separate CT scanner.

HyperSight on TrueBeam and Edge acquires images for all anatomical sites with a 50% faster gantry rotation, significantly reducing acquisition time. In contrast, traditional CBCT scans can take up to 60 seconds, depending on the anatomical site being scanned. A reduction in CBCT acquisition time reduces motion-related artifacts due to patient movement. A shorter image acquisition time may minimize patient discomfort and anxiety due to less time on the treatment table.

The Cancer Institute at Northwell Lenox Hill in New York was one of the early adopters of HyperSight imaging on their Halcyon system. "HyperSight imaging has allowed us to improve patient comfort by decreasing the time patients spend on the treatment table while simultaneously targeting with greater confidence," said Dr. Wesley Talcott, Assistant Professor and Radiation Oncologist, Department of Radiation Medicine at Lenox Hill Hospital. "We look forward to further streamlining care for our patients using HyperSight."

Initially launched in 2022 on Varian's Ethos and Halcyon therapy systems, HyperSight has been gaining popularity among clinicians and researchers alike. With nine studies either conducted, in progress, or to be initiated across eight institutions, Varian is committed to better understanding the role HyperSight may play in advancing care and enhancing the patient experience. The customer-led Intelligent Imaging Consortium, created by Varian, offers HyperSight users a forum to collaborate and innovate on trials and studies.

"As a Siemens Healthineers company, we are pioneering innovative solutions to advance radiotherapy and connect the power of imaging, both inside and outside the treatment room," said Arthur Kaindl, Head of Varian. "We are excited to expand HyperSight imaging technology to our TrueBeam and Edge platforms and further collaborate with our clinical partners to provide an integrated portfolio that connects the dots along the cancer care continuum."

The statement by Varian's customer described above is based on results achieved in the customer's unique clinical setting. Because there is no "typical" clinical setting and many variables exist, there is no guarantee that other customers will achieve the same results.

VARIAN, TRUEBEAM, EDGE, ETHOS, HALCYON, HYPERSIGHT are trademarks of Varian Medical Systems, Inc., pending or registered U.S. Pat. & Tm. Off.

About Varian
At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 75 years, Varian has developed, built, and delivered innovative technologies and solutions that help care providers around the globe treat millions of patients each year. Today, as a Siemens Healthineers company, we support every step of the cancer care journey – from screening to survivorship. From advanced imaging and radiation therapy, to comprehensive software and services, to interventional radiology, we are harnessing the power of our perspective while also pursuing clinical research to create a more efficient, and more personalized care pathway. Because, for cancer patients everywhere, their fight is our fight. For more information, visit

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