Accuray Receives Shonin Approval for ClearRT™ Helical kVCT Imaging, CE Mark Expected by End of June; Expands Commercial Launch
High-quality images are central to all aspects of the radiation therapy treatment workflow. ClearRT high-fidelity helical kVCT imaging enables high confidence in the patient set-up and registration that form the basis of radiation therapy treatment planning, delivery and monitoring, and are key to the successful treatment of organ-confined tumors, locally advanced tumors and metastatic tumors.
First Patient Treatments Show Imaging Technology's Promise
The medical care team at
"At Willis-Knighton, we have always tried to introduce next-generation radiotherapy technology. The Radixact System with ClearRT has the potential to change clinical practice. The ClearRT daily targeting images exceeded our expectations, and provided noticeably superior image quality compared to more traditional cone-beam CT available on conventional linear accelerators. The Radixact System with ClearRT imaging will allow our team to improve the care we provide our cancer patients by better visualization of tumors and adaptive therapy," said
Regulatory Approvals Expand Access
ClearRT received Shonin approval from the
Commercial Shipments Begin on Schedule
"We are proud to partner with
*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.
Important Safety Information
For Important Safety Information please refer to https://www.accuray.com/safety-statement.
About
Safe Harbor Statement
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 potential of ClearRT to change the field of radiation oncology and clinical practice, the anticipated timing for CE Mark approval for the ClearRT and accessibility of ClearRT to EU customers, the anticipated timing for full production release of ClearRT, 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, including new product innovations and releases; 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
Forward-looking statements speak only as of the date the statements are made and are based on information available to the company at the time those statements are made and/or management's good faith belief as of that time with respect to future events. The company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not put undue reliance on any forward-looking statements.
Media Contact
+1 (408) 789-4426
bkaplan@accuray.com
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