Accuray receives 510(k) FDA clearance for ClearRT Helical kVCT Imaging for the Radixact treatment delivery system

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Accuray receives 510(k) FDA clearance for ClearRT Helical kVCT Imaging for the Radixact treatment delivery system

Press releases may be edited for formatting or style | January 05, 2021 CT X-Ray
SUNNYVALE, Calif., Jan. 5, 2021 /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 ClearRT™ Helical kVCT Imaging* for the Radixact® System, the next generation TomoTherapy® platform. ClearRT is a cutting-edge imaging solution integrated with a powerful, precise, and adaptive delivery platform, designed to produce exceptional diagnostic-like quality CT images, quickly and cost-effectively, to improve patient care. Accuray is planning commercial release of the ClearRT Helical kVCT Imaging for the Radixact System in the Spring of 2021.

ClearRT delivers enhanced imaging capabilities compared to conventional linear accelerator systems that rely on cone-beam CT (CBCT) imaging and as an alternative to MR-based radiation therapy systems that can be complex and cost prohibitive to use. ClearRT offers excellent uniformity and low noise across the entire image, improved soft tissue visualization and exceptional spatial resolution, which is intended to enhance the versatility and efficiency of the Radixact System in the radiation therapy department.

The ClearRT imaging solution is seamlessly integrated into the Radixact System. Helical fan-beam imaging available at both kV and MV wavelengths provides medical care teams the flexibility to fulfill the patient imaging requirements necessary for accurate patient setup and registration, including imaging patients with metal implants contraindicated for MR imaging. Enabling a "meter in a minute" image acquisition, ClearRT helical kVCT provides the industry's largest transverse field of view and the longest continuous scan length – facilitating fast and easy set-up of any patient requiring radiation treatment and giving clinicians the versatility needed to treat the widest range of indications with confidence.

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ClearRT leverages the same simple 5-step delivery workflow that makes the Radixact System easy to use, and easy to adopt. Clear, high-fidelity images will reduce the time required for patient imaging and registration, a crucial part of the treatment delivery process, thereby enabling clinical staff to serve more patients. Additionally, ClearRT helical kVCT images will be available within the Accuray PreciseART® automated dose trending tool for clinicians to evaluate if plan adaptation would be beneficial, enabling the most personalized patient care.

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