CLEVELAND, Feb. 21, 2019 /PRNewswire/ -- ViewRay, Inc.
(Nasdaq: VRAY), announced today that the company received 510(k)
clearance from the U.S. Food and Drug Administration (FDA) to
market new soft tissue visualization capabilities for its MRIdian
system.
The new upgradable capabilities enhance
the industry-leading features of MRIdian's SmartVISION MRI,
including:
- Expanded high-definition visualization and enhanced contrast
between different tissues, to assist clinicians with tissue
visualization and beam contouring
- The potential to aid in the assessment and prediction of tumor
response to radiation therapy is enabled by "DWI", our
diffusion weighted imaging feature which tracks treatment
progress by distinguishing between tumor and normal tissues
- Faster, brighter, more detailed anatomical planar imaging to
strike tumors with greater precision and accuracy through our
proprietary technology, which allows for a 2X increase in MR
imaging speed (to 8 frames per second), a 2X increase in image
resolution, and a 2X improvement in MR signal-to-noise ratio
(SNR)
- Potential reduction in treatment delivery time through enhanced
MLC speed
"Today we announce another significant step forward in our drive
to better treat cancer patients and further differentiate MRIdian
in the marketplace", said James
Dempsey, Ph.D., Founder and Chief Scientific Officer of
ViewRay. "Our customers are seeking significant improvements on
imaging speed, resolution and brightness. They also demand that we
avoid artifacts and distortions that have historically and
consistently plagued the field. We believe these innovations hit
the mark. We will continue to advance the field of MR Guided
Radiation Therapy and expand the application of the MRIdian
system."
MRIdian's SmartVISION provides high-definition,
diagnostic-quality MR imaging. SmartVISION was designed to maintain
high-fidelity beam delivery, while mitigating the risks of skin
toxicities, as well as trapped or distorted dose. MRIdian's
SmartADAPT helps allow clinicians to generate daily MR setup scans
in seconds and leverage high-contrast anatomical detail to rapidly
reshape dose delivery based on the current position of both the
tumor and adjacent critical structures – all while the patient is
in the treatment position. MRIdian's SmartTARGET visualizes the
tumor's edges and surrounding organ position in real-time using a
non-ionizing, streaming video perspective. When tumors or
organs-at-risk change shape or position, SmartTARGET instantly
reacts, automatically controlling beam delivery.
About ViewRay®
ViewRay, Inc. (Nasdaq: VRAY), designs, manufactures and markets the
MRIdian® radiation therapy system. MRIdian is built upon a
proprietary high-definition MR imaging system designed from the
ground up to address the unique challenges and clinical workflow
for advanced radiation oncology. Unlike MR systems used in
diagnostic radiology, MRIdian's high-definition MR was
purpose-built to address specific challenges, including beam
distortion, skin toxicity, and other concerns that potentially may
arise when high magnetic fields interact with radiation beams.
ViewRay and MRIdian are registered trademarks of ViewRay, Inc.
Intended Use: The MRIdian Linac System, with
magnetic resonance imaging capabilities, is intended to provide
stereotactic radiosurgery and precision radiotherapy for lesions,
tumors, and conditions anywhere in the body where radiation
treatment is indicated.
Forward Looking Statements: This press release contains
forward-looking statements. Statements in this press release that
are not purely historical are forward-looking statements. These
statements are subject to risks and uncertainties that could cause
future results to differ materially from those referenced.
Forward-looking statements include, but are not limited to,
statements about ViewRay's financial results and market acceptance
of ViewRay's existing products, future products or technology.
Words such as "could," "anticipates," "expects," "outlook,"
"intends," "plans," "believes," "seeks," "vision," "estimates,"
"may," "will," "future," "horizon," "aiming," "driving," "target"
(or variations of them) and similar statements, are forward-looking
statements. Forward-looking statements involve risks, uncertainties
and assumptions that are difficult to predict and could cause
ViewRay's results to differ materially from those presented. These
risks, uncertainties and assumptions include, but are not limited
to, changes in: the regulatory environment; global economics; trade
compliance requirements, duties or tariffs; third-party
reimbursement levels; currency exchange rates; taxation, healthcare
law, and product clearance requirements, as well as those related
to: adverse publicity about ViewRay and our products; our reliance
on sole or limited source suppliers; our ability to commercialize
our products successfully; the impact of competitive products and
pricing, and all other risks listed from time to time in the
company's filings with the Securities and Exchange Commission,
available at www.sec.gov, which are incorporated into this
Forward-Looking Statements disclosure by this reference. These
forward-looking statements are made as of the date of this press
release, and ViewRay assumes no obligation to update the
forward-looking statements, or to update the reasons why actual
results differ from those projected in the forward-looking
statements, except as required by law.
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SOURCE ViewRay, Inc.