Asensus Surgical Receives FDA 510(k) Clearance for Expansion of Machine Vision Capabilities
01 Setembro 2021 - 9:00AM
Business Wire
Additional Intelligent Surgical Unit™ (ISU™)
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 received 510(k) clearance from the FDA for an
expansion of machine vision capabilities on the previously cleared
Intelligent Surgical Unit™ (ISU™). The ISU is utilized with the
Company’s SenhanceⓇ Surgical System which enables Digital
Laparoscopy.
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the full release here:
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The Senhance Surgical System pictured
with the latest ISU model that includes expanded augmented
intelligence features such as 3D measurement and enhanced camera
control. (Graphic: Business Wire)
“We are thrilled to have received FDA clearance for our next
generation of augmented intelligence features on the ISU,” said
Anthony Fernando, Asensus Surgical President and CEO. “The addition
of these pioneering digital capabilities on our existing surgical
platform provides real-time intraoperative digital tools to
surgeons and underscores our commitment to delivering our vision
for Performance-Guided Surgery. This is the latest example of our
progress toward delivering on our Surgical Assurance Framework by
unlocking the clinical intelligence necessary to enable
consistently superior outcomes and a new standard of surgery.”
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 allow a surgeon to change the visualized field of view using
the movement of their instruments. The newest ISU features expand
upon these capabilities and introduce more advanced features
including: 3D measurement, digital tagging, image enhancement, and
enhanced camera control based on real-time data from anatomical
structures while performing surgery. This will be the first time
any of these features will be clinically available in soft-tissue
abdominal surgery.
“This is a new era in digital surgery,” said Dr. Amit Trivedi,
chair of surgery at Hackensack Meridian Health Pascack Valley
Medical Center and an active user of the Senhance ISU with over one
hundred cases completed utilizing the ISU. “The ability to
intraoperatively measure with millimeter accuracy in real-time,
place digital tags and know that the system keeps track of the
instruments at all times are game-changers in surgery. I am very
excited about these new features and the future innovations of the
ISU’s digital technologies for surgeons.”
“Utilizing real-time 3D measurement tools would be valuable to
evaluate margins and estimate defect sizing,” said Dr. Michael Cook
of University Medical Center - New Orleans. “Digital tagging is a
major advancement to pinpoint specific anatomical locations during
the course of a complex operation that may be utilized as landmarks
and teaching aides. Surgical robots have the potential to become
decision support tools, and these new features help realize that
potential.”
The 3D measurement feature enables the surgeon to use their
instruments to designate points on the tissue floor to determine
both straight-line distances as well as true topographic distances
over the folds and recesses of the abdominal cavity. In traditional
minimally invasive surgery, such measurements are estimated or
require the use of a sterile measuring tape inside the abdominal
cavity. Now 3D measurement allows for accurate readings to
millimeter-level accuracy that can assist in various surgical
tasks, such as the sizing of hernia mesh or the planning of a
staple line. These measurement capabilities represent the first
time surgeons have the ability to acquire accurate, real-time
measurements without the need for additional tools.
Digital tagging introduces a new surgeon capability to make
dynamic annotations on the live surgical camera view for real-time
guidance and planning. Further, real-time underlying anatomy
monitoring allows tags to persist through intraoperative camera
movement. This has the potential to gain procedural efficiencies
and delivers dynamic digital markers which preserves the tag
locations while tissue is being manipulated.
Image enhancement dynamically adjusts the brightness and
contrast of the surgical scene to provide a clear and consistent
image, adaptively compensating for uneven illumination. Image
enhancement facilitates high-quality video acquisition, which is a
cornerstone of Performance-Guided Surgery. Because this feature is
vision system agnostic, this benefit can be realized with all
vision systems that are compatible with Senhance.
Enhanced camera control builds on existing methods of
instrument-based camera control and directs camera positioning
based on the tracked location of multiple instruments within the
scene and allows for automatic adjustment of pan and zoom
simultaneously to maintain visualization of the instruments. Always
maintaining visualization of instruments in the field of view is a
best practice for performing safe surgery.
The clearance of these expanded augmented intelligence features
demonstrates the Company's commitment to delivering on the promise
of Performance-Guided Surgery. The Company believes these
additional features will provide meaningful support for surgeons
across a range of specialties and procedures. Additionally, the
foundational elements of these features will enable the Company to
continue introducing novel augmented intelligence features in the
future by leveraging the vast capabilities and potential of the
ISU.
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 the FDA 510(k) clearance for expansion of
machine vision capabilities. 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 additional ISU features will further extend
augmented intelligence leadership in surgery, whether the expanded
ISU features, including 3D measurement, digital tagging, image
enhancement and enhanced camera control based on real-time data
from anatomical structures while performing surgery will be the
first time to be clinically available in soft-tissue abdominal
surgery and whether the ISU’s additional features will provide
meaningful support for surgeons across a range of specialties and
procedures. 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/20210901005345/en/
INVESTOR CONTACT: Mark Klausner or Mike Vallie,
443-213-0499 invest@asensus.com or MEDIA CONTACT: Kristin
Schaeffer CG Life kschaeffer@cglife.com
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