Intuitive Submits New Robotic-Assisted Platform to FDA for Obtaining Lung Biopsies
September 06 2018 - 8:55AM
Intuitive Surgical, Inc. (Nasdaq: ISRG), the pioneer and a global
technology leader in robotic-assisted, minimally invasive surgery,
today announced it has submitted a premarket notification to the
U.S. Food and Drug Administration (FDA) for the company’s new
flexible robotic-assisted, catheter-based platform, designed to
navigate through very small lung airways to reach peripheral
nodules for biopsies.
Lung cancer is the world’s leading cause of cancer deaths. The
majority of suspicious lesions found in the lung are small and
difficult to access, which can make obtaining a diagnosis
challenging.
Intuitive brings more than two decades of leadership in
robotic-assisted surgical technology and solutions to this
innovative new platform, which supports the company’s leadership in
the advancement of minimally invasive care.
Premarket notification is one of the regulatory processes that
the FDA uses to review information about medical devices before
they are allowed to be marketed in the U.S.
About Intuitive Surgical, Inc.
Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in
Sunnyvale, Calif., is the pioneer and a global leader in
robotic-assisted, minimally invasive surgery. Intuitive Surgical
develops, manufactures and markets the da Vinci® surgical
system.
Forward Looking Statements
This press release contains forward-looking statements,
including statements regarding the flexible robotic-assisted,
catheter-based platform’s design and the company’s leadership in
the advancement of minimally invasive care. These forward-looking
statements are necessarily estimates reflecting the best judgment
of the company’s management and involve a number of risks and
uncertainties that could cause actual results to differ materially
from those suggested by the forward-looking statements. These
forward-looking statements should, therefore, be considered in
light of various important factors, including, but not limited to,
the following: the risk that the FDA will not clear the flexible
robotic-assisted, catheter-based platform device for commercial
distribution under the premarket notification process or otherwise;
other regulatory approvals, clearances and restrictions or any
dispute that may occur with any regulatory body; the impact of
global and regional economic and credit market conditions on
healthcare spending; healthcare reform legislation in the United
States and its impact on hospital spending, reimbursement and fees
levied on certain medical device revenues; changes in hospital
admissions and actions by payers to limit or manage surgical
procedures; the timing and success of product development and
market acceptance of developed products, including, but not limited
to, the recently cleared da Vinci SP Surgical System and 3rd
generation stapling platform; the results of any collaborations,
in-licensing arrangements, joint ventures, strategic alliances or
partnerships; procedure counts; guidelines and recommendations in
the healthcare and patient communities; intellectual property
positions and litigation; competition in the medical device
industry and in the specific markets of surgery in which the
company operates; unanticipated manufacturing disruptions or the
inability to meet demand for products; the results of legal
proceedings to which the company is or may become a party; product
liability and other litigation claims; adverse publicity regarding
the company and the safety of the company’s products and adequacy
of training; the company’s ability to expand into foreign markets;
the impact of changes to tax legislation, guidance, and
interpretations; and other risk factors under the heading “Risk
Factors” in the company’s annual report on Form 10-K for the year
ended December 31, 2017, as updated by the company’s other filings
with the Securities and Exchange Commission. Statements using words
such as “estimates,” “projects,” “believes,” “anticipates,”
“plans,” “expects,” “intends,” “may,” “will,” “could,” “should,”
“would,” “targeted” and similar words and expressions are intended
to identify forward-looking statements. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date of this press release. The company
undertakes no obligation to publicly update or release any
revisions to these forward-looking statements, except as required
by law.
ContactGlobal Public AffairsIntuitive
Surgicalcorp.comm@intusurg.com +1-408-523-7337
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