Accuray Receives 510(k) Clearance for a Rotational Dose Control for the TomoTherapy System
SUNNYVALE, Calif., Oct. 25, 2011 /PRNewswire/ – Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market the Dose Control System (DCS), a new feature for Accuray’s TomoTherapyÃ‚® System that improves system performance.
The TomoTherapy System revolutionized radiation therapy with the introduction of helical delivery, providing precise application of dose to target structures while sparing healthy tissue. With the advent of the Dose Control System the TomoTherapy System again breaks new ground as the first dose servo-controlled helical delivery system (patent pending). This approach provides even higher precision with unprecedented dose stability throughout complex rotational treatments. Static delivery provided by the TomoDirect(TM) option also benefits from a more stable and consistent dose rate at every gantry angle.
The new DCS feature provides these gains by automatically adjusting controls previously handled through a manual process. This means small variations in dose rate are immediately corrected by the system, resulting in fewer interruptions. The DCS application also ensures a more stable output over longer duration treatments, such as Total Marrow and Total Body Irradiation. The result of this new product feature is higher customer satisfaction, a better patient experience, and improved overall system performance.
“FDA clearance of the new Dose Control System is a positive step toward improving TomoTherapy System performance and customer satisfaction,” said Euan S. Thomson, Ph.D., president and chief executive officer of Accuray. “We are dedicated to offering our customers technological advancements that help streamline their workflow and expand the capabilities of their systems.”
With the FDA 510(k) clearance, the DCS application is now available for purchase in the United States. Interested customers can contact their Accuray sales representative or send an email to email@example.com for more information.
Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company that develops, manufactures and sells personalized innovative treatment solutions that set the standard of care, with the aim of helping patients live longer, better lives. The Company’s leading edge technologies – the CyberKnife and TomoTherapy Systems – are designed to deliver radiosurgery, stereotactic body radiation therapy, intensity modulated radiation therapy, image-guided radiation therapy and adaptive radiation therapy. To date, more than 200,000 patients worldwide have been treated using the Company’s technologies and more than 582 systems have been installed in leading hospitals around the world. For more information, please visit www.accuray.com.
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The foregoing may contain certain forward-looking statements that involve risks and uncertainties, including uncertainties associated with the medical device industry. Except for the historical information contained herein, the matters set forth in this press release, including statements relating to precision, stability and system performance; customer satisfaction and patient experience are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. You should not put undue reliance on any forward-looking statements. Important factors that could cause actual performance and results to differ materially from the forward-looking statements we make include: system performance, clinical benefits, and market acceptance of products and other risks detailed from time to time under the heading “Risk Factors” in our report on Form 10-K for our 2011 fiscal year filed on September 19, 2011 and our other filings with the Securities and Exchange Commission. The Company’s actual results of operations may differ significantly from those contemplated by such forward-looking statements as a result of these and other factors. We assume 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.
SOURCE Accuray Incorporated