SUNNYVALE, Calif., Jan. 5, 2021 /PRNewswire/ -- Accuray
Incorporated (NASDAQ: ARAY) announced today that the company has
received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its ClearRT™ Helical kVCT Imaging* for the
Radixact® System, the next generation
TomoTherapy® platform. ClearRT is a
cutting-edge imaging solution integrated with a powerful, precise,
and adaptive delivery platform, designed to produce exceptional
diagnostic-like quality CT images, quickly and cost-effectively, to
improve patient care. Accuray is planning commercial release of the
ClearRT Helical kVCT Imaging for the Radixact System in the Spring
of 2021.
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
Accuray-only applications, such as Synchrony® Real-time
Motion Synchronization and Adaptive Treatment Delivery Technology,
on the Radixact System, making it possible for providers to offer a
new level of precision and accuracy in the treatment of the
simplest to the most complex pathologies," said Suzanne Winter, chief commercial officer and
senior vice president, R&D at Accuray. "Our continuing
innovation on the Radixact System is designed to leverage the power
of its 360-degree, helical delivery platform to facilitate
advanced, hypofractionated and ultra-hypofractionated treatments
that support our customers' efforts to maintain the highest
standard of care for their community."
*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.
About Accuray
Accuray is committed to expanding the powerful potential of
radiation therapy to improve as many lives as possible. We invent
unique, market-changing solutions to deliver radiation treatments
for even the most complex cases—while making commonly treatable
cases even easier—to meet the full spectrum of patient needs. We
are dedicated to continuous innovation in radiation therapy for
oncology, neuro-radiosurgery, and beyond, as we partner with
clinicians and administrators, empowering them to help patients get
back to their lives, faster. Accuray is headquartered in
Sunnyvale, California, with
facilities worldwide. To learn more, visit www.accuray.com or
follow us on Facebook, LinkedIn, Twitter, and YouTube.
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 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 Securities
and Exchange Commission (the "SEC") on November 4, 2020, 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 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
Beth Kaplan
Accuray
+1 (408) 789-4426
bkaplan@accuray.com
Investor Contact
Joe Diaz
Investor Relations, Lytham Partners
+1 (602) 889-9700
diaz@lythampartners.com
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SOURCE Accuray Incorporated