Healthcare Industry News: U.S. Food and Drug Administration
News Release - July 31, 2017
Accuray Receives 510(k) Clearance for iDMS(TM) Data Management System Upgrade for the TomoTherapy(R) SystemiDMS System Allows Seamless Integration between Accuray Radixact™, TomoTherapy® and CyberKnife® Systems and Treatment Planning Systems
SUNNYVALE, Calif., July 31, 2017 -- (Healthcare Sales & Marketing Network) -- Accuray Incorporated (NASDAQ: ARAY) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its iDMS™ Data Management System, enabling its use with the Company's TomoTherapy® platform. It's designed to integrate with a wide range of technologies, including the Radixact™, TomoTherapy® and CyberKnife® Systems, Accuray Precision™ Treatment Planning System, and third-party treatment planning and oncology information systems.
The iDMS System is a centralized database that shares and makes data accessible between multiple Accuray treatment delivery systems, adding flexibility and improving efficiency in the radiation therapy department. It provides an integrated platform for storing and managing all patient and treatment plan data, allowing clinicians to securely and seamlessly access the data they need to drive efficient, informed, effective radiation treatments.
"This most recent clearance reinforces Accuray's commitment to providing clinicians with options for seamless, fully integrated treatment planning and data management, enhancing department workflow efficiency," said Lionel Hadjadjeba, Senior Vice President, and Chief Commercial Officer at Accuray. "The common database will make it possible for clinicians to use any available Accuray treatment system, expanding patient access to the precision and treatment versatility of our advanced radiation therapy systems."
Accuray Incorporated (NASDAQ: ARAY) is a radiation oncology company that develops, manufactures, and sells precise, innovative tumor treatment solutions that set the standard of care with the aim of helping patients live longer, better lives. The Company's leading-edge technologies deliver the full range of radiation therapy and radiosurgery treatments. For more information, please visit www.accuray.com
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 clinical applications, market acceptance of our new technologies, and Accuray's leadership position in radiation oncology innovation and technologies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including but not limited to the risks detailed from time to time under the heading "Risk Factors" in the company's report on Form 10-K, filed on August 24, 2016, the company's reports on Form 10-Q, filed on November 1, 2016, February 3, 2017, and May 5, 2017, and as updated periodically with the company's other filings with the SEC.
Forward-looking statements speak only as of the date the statements are made and are based on information available to Accuray 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.
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