Asensus Surgical Receives FDA 510(k) Clearance for Articulating Instruments
28 Julho 2021 - 10:00AM
Business Wire
Instrument platform expected to expand
dexterity and add capability to Senhance® Surgical System
Asensus Surgical, Inc. (NYSE American: ASXC), a medical device
company that is digitizing the interface between the surgeon and
patient to pioneer a new era of Performance-Guided Surgery™, today
announced that it has received FDA 510(k) clearance for 5 mm
diameter articulating instruments, adding to the Senhance Surgical
System technology platform. Articulating instruments offer better
access to difficult-to-reach areas of the anatomy by providing two
additional degrees of freedom. These instruments have previously
received CE Mark for use in the European Union.
“Bringing the benefits of 5 mm articulating instruments to the
Senhance Surgical System in the U.S. will widen the clinical
utility and value of our platform,” said Anthony Fernando, Asensus
Surgical President and CEO. “Combining articulation and haptics
with augmented intelligence is a very promising development for
Performance-Guided Surgery."
Asensus Surgical's technology platform, the Senhance Surgical
System, is the first of its kind digital laparoscopic platform that
leverages augmented intelligence to provide unmatched performance
and patient outcomes through machine learning. Senhance goes beyond
the typical surgical robotic systems, providing surgical assurance
through haptic feedback, eye-tracking camera control, and 3D
visualization, and is the first platform to offer 3 mm instruments.
Articulating instruments are the latest addition to the Senhance
Surgical System in the United States, further enhancing surgical
performance with robotic precision.
About Asensus Surgical, Inc.
Asensus Surgical, Inc. is digitizing the interface between the
surgeon and patient to pioneer a new era of Performance-Guided
Surgery by unlocking the clinical intelligence to enable
consistently superior outcomes and a new standard of surgery. This
builds upon the foundation of Digital Laparoscopy with the Senhance
Surgical System powered by the Intelligent Surgical Unit™ (ISU™) to
increase surgeon control and reduce surgical variability. With the
addition of machine vision, augmented intelligence, and deep
learning capabilities throughout the surgical experience, we intend
to holistically address the current clinical, cognitive and
economic shortcomings that drive surgical outcomes and value-based
healthcare. Learn more about Performance-Guided Surgery and Digital
Laparoscopy with the Senhance Surgical System here:
www.senhance.com. Now available for sale in the US, EU, Japan,
Russia, and select other countries. For a complete list of
indications for use, visit: www.senhance.com/indications. For more
information, visit www.asensus.com.
Forward-Looking Statements
This press release includes statements relating to the Senhance
Surgical System and the FDA 510(k) clearance for articulating
instruments. These statements and other statements regarding our
future plans and goals constitute "forward looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, and are
intended to qualify for the safe harbor from liability established
by the Private Securities Litigation Reform Act of 1995. Such
statements are subject to risks and uncertainties that are often
difficult to predict, are beyond our control and which may cause
results to differ materially from expectations and include whether
the benefits of 5 mm articulating instruments to the Senhance
Surgical System will widen clinical utility and value of our
platform, and whether articulating instruments will expand
dexterity and add capabilities to the Senhance Surgical System .
For a discussion of the risks and uncertainties associated with the
Company’s business, please review our filings with the Securities
and Exchange Commission (SEC), including our Annual Report on Form
10-K for the year ended December 31, 2020, filed with the SEC on
March 11, 2021 and our other filings we make with the SEC. You are
cautioned not to place undue reliance on these forward looking
statements, which are based on our expectations as of the date of
this press release and speak only as of the origination date of
this press release. We undertake no obligation to publicly update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20210728005560/en/
INVESTOR CONTACT: Mark Klausner or Mike Vallie,
443-213-0499 invest@asensus.com or MEDIA CONTACT: Kristin
Schaeffer CG Life kschaeffer@cglife.com
Asensus Surgical, Inc. (NYSE:ASXC)
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