Asensus Surgical Announces 510(k) Submission to FDA for Machine Vision Capabilities Expansion
14 Julho 2021 - 7:55AM
Business Wire
Additional Intelligent Surgical Unit™ features
will further extend augmented intelligence leadership in
surgery
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 filed a 510(k) submission with the FDA for an
expansion of capabilities on the previously cleared Intelligent
Surgical Unit™ (ISU™). The ISU is utilized on the Company’s
Senhance Surgical System which enables digital laparoscopy.
“The expansion of augmented intelligence capabilities is the
next driver of performance in digital surgery,” said Anthony
Fernando, Asensus Surgical President and CEO. “This submission is
an important milestone in our continued leadership with machine
vision and augmented intelligence in surgery. We believe these new
capabilities will support surgical planning, decision support and
teaching.”
The current features of the ISU enable machine vision driven
control of the camera for a surgeon by responding to commands and
recognizing certain objects and locations in the surgical field and
allows a surgeon to change the field of view using instruments. The
new features would expand to include more advanced features to
gather real time data during surgery based on the anatomical
structures in the surgical field.
“I am enthusiastic about the new capabilities which will soon be
added to the Senhance Surgical System,” said Dr. Amit Trivedi,
chair of surgery at Hackensack Meridian Health Pascack Valley
Medical Center. “These new features would provide planning tools
that haven’t existed before in digital and robotic surgery and
allow me to perform more consistent surgery.”
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. 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 our 510(k) submission to FDA for machine vision
capabilities expansion. 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 FDA will clear this 510(k) submission, whether
expansion of augmented intelligence capabilities will be the next
driver of performance in digital surgery, whether these new
capabilities will support surgical planning, decision support and
teaching and whether the new features included in the 510(k)
submission would expand to include more advanced features to gather
real time data during surgery based on the anatomical structures in
the surgical field. 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/20210714005287/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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