Accuray Receives 510(k) FDA Clearance for ClearRT™ Helical kVCT Imaging for the Radixact® Treatment Delivery System
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.
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.
"ClearRT is a novel, helical CT imaging solution that we believe addresses an unmet market need. It integrates with other
*ClearRT Helical kVCT Imaging for the Radixact® Treatment Delivery System is not available for sale in all markets. ClearRT may be subject to international regulatory approval or licensing processes such that the availability of these products may vary according to geographical location.
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Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to the anticipated timing for the ClearRT™ commercial release and its ability to address unmet market needs, clinical applications, clinical results, patient experiences and patient outcomes. These forward-looking statements involve risks and uncertainties. If any of these risks or uncertainties materialize, or if any of the company's assumptions prove incorrect, actual results could differ materially from the results expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the company's ability to achieve widespread market acceptance of its products; the company's ability to develop new products or improve existing products to meet customers' needs; the company's ability to anticipate or keep pace with changes in the marketplace and the direction of technological innovation and customer demands and such other risks identified under the heading "Risk Factors" in the company's quarterly report on Form 10-Q, filed with the
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