LeadVarian Receives FDA 510(k) Clearance for TrueBeam and Edge Radiotherapy Systems

Varian Receives FDA 510(k) Clearance for TrueBeam and Edge Radiotherapy Systems

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March 2024- 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 to improve patient outcomes.

HyperSight imaging allows clinicians to acquire high-quality images during a patient’s daily course of radiation treatments. The enhanced image quality aims to improve the ability to target tumor volumes more precisely and spare healthy tissue for patients undergoing 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 enables adaptive planning to adjust for anatomical changes to the tumor and surrounding organs over the course of treatment without requiring 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. Contrastingly, depending on the anatomical site being scanned, traditional CBCT scans can take up to 60 seconds. 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.

Initially launched in 2022 on Varian’s Ethos and Halcyon therapy systems, HyperSight has been gaining popularity among clinicians and researchers alike. Varian, across eight institutions, is actively conducting, progressing, or initiating nine studies to better understand HyperSight’s role 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.

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“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.”

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