SUNNYVALE, Calif., April 26, 2016 /PRNewswire/ -- Accuray
Incorporated (NASDAQ: ARAY) announced today the submission of its
510(k) premarket notification with the Food and Drug Administration
(FDA) for the company's Radixact™ Treatment Delivery System.
Accuray also submitted 510(k) premarket notification for its
treatment planning and data management systems, Precision™
Treatment Planning System and iDMS™ Data Management System.
The treatment delivery system, Precision Treatment Planning
System, and iDMS Data Management System have been designed to
seamlessly work together and improve treatment workflow processes.
Multiple Radixact Systems may use a single, centralized database
for treatment planning and patient data management.
"The Radixact System is the next generation
TomoTherapy® platform and is being designed to leverage
its unique architecture, providing a mainstream option for more
clinicians. The new platform, comprised of the treatment delivery,
treatment planning and data management systems, is expected to
expand clinical capabilities while significantly increasing the
ease and speed with which clinicians can provide precise radiation
treatments," said Joshua H. Levine,
president and chief executive officer of Accuray. "The Radixact
System will provide the foundation for continued innovation in the
months and years ahead. Working with clinicians we will continue
the development of clinically relevant, leading-edge technologies
with the potential to truly change the radiation therapy treatment
experience."
The next generation platform is designed for increased
throughput, higher reliability and ease of serviceability. The ring
gantry-based delivery system will offer the same proven
gold-standard delivery capabilities as today's devices:
TomoHelical™ and TomoDirect™ treatment modes. The high output,
compact linear accelerator will be capable of producing a dose rate
of 1,000 MU per minute, and imaging speed will increase. The
integrated treatment planning system is intended to reduce workflow
complexities and save time in the treatment planning process.
Clinicians at the University of
Wisconsin-Madison played an important role in developing
this newest radiation therapy system, collaborating with Accuray to
ensure the Radixact System design objectives were met.
"The University of Wisconsin team is
excited to be involved in the development of a new radiation
therapy technology which builds upon the pioneering work initiated
here," said Jennifer Smilowitz, PhD,
clinical associate professor University of
Wisconsin School of Medicine and Public Health. "We look
forward to sharing the initial experiences of our Radixact System
work at the ESTRO meeting in Turin,
Italy on Sunday, May 1, 2016
at 10:05 am – 10:25 am and
2:00 pm – 2:20
pm, Accuray booth #1300."
*The Radixact Treatment Delivery System, Precision Treatment
Planning System and iDMS Data Management System are pending FDA
510(k) clearance and not available for sale within the United States. These products may also be
subject to international regulatory approval or licensing processes
such that the availability of these products may vary according to
geographical location.
About Accuray
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,
clinical results, anticipated regulatory approvals and launches of
new products, market uptake of recently launched products, market
growth 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 28, 2015, the company's
reports on Form 10-Q, filed on November 5,
2015 and February 1, 2016, and
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.
Media Contacts:
Beth Kaplan
Accuray
+1 (408) 789-4426
bkaplan@accuray.com
Kirsten Fallon
MSLGROUP in Boston
+1 (781) 684-0770
accuray@MSLGROUP.com
Investor Contact:
Chris Dailey
Investor Relations, EVC Group
+1 (646) 445-4801
cdailey@evcgroup.com
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SOURCE Accuray Incorporated