MADISON, Wis., Aug. 9, 2023 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VitalHold™* breast package on the Radixact® System. The treatment option will also be available in the EU market. VitalHold facilitates deep inspiration breath hold (DIBH) treatments using the Radixact System's fixed beam angle delivery mode (TomoDirect™) and a fully integrated and automated surface-guided radiation therapy (SGRT) solution, featuring the Catalyst+ HD system from C-RAD. With the addition of this new functionality, the Radixact System offers a comprehensive tool set for the treatment of breast cancer. The VitalHold technology will be available to customers in the United States and European Union as well as other regions, subject to regulatory clearance or approvals.

DIBH treatments are often used to help minimize radiation dose to organs at risk (OARs) and reduce associated complications later in life. During treatment, a patient takes a deep breath which moves the heart away from the chest wall and the targeted tumor. The SGRT tracking system continuously monitors a patient's breathing and position with cameras to confirm the patient is appropriately positioned to deliver radiation. SGRT is designed to enable medical care teams to effectively position the patient and confidently monitor the accuracy of that positioning throughout treatment.

"Our goal in introducing VitalHold for the Radixact System is to provide clinicians with additional choice and flexibility when treating the full spectrum of breast cancer cases they see daily in their practice. Now, Accuray can offer our customers the widest range of radiation treatment delivery techniques in one device, the Radixact System. This industry-leading approach demonstrates how our relentless focus on innovation has enabled Accuray to make an already great system even better, providing clinicians with tools that help ensure precise, truly personalized treatments are achievable for more patients," said Suzanne Winter, President and CEO of Accuray.
"C-RAD is incredibly proud of our collaboration with Accuray. Together, we have created a seamless integration between our systems to ensure the highest level of accuracy and efficiency for the treatment of breast cancer," said Cecilia de Leeuw, CEO and President of C-RAD AB. "VitalHold is a powerful application of C-RAD's proven SGRT technology — and one that's sure to touch the lives of countless breast cancer patients."

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