TransEnterix Announces Submission of 510(k) to FDA for First Machine Vision System in Robotic Surgery
January 14 2020 - 6:55AM
Business Wire
New Technology Would Enable Augmented
Intelligence with the Senhance Surgical System
TransEnterix, Inc. (NYSE American: TRXC), a medical device
company that is digitizing the interface between the surgeon and
the patient to improve minimally invasive surgery, today announced
the Company filed a 510(k) submission with an Intelligent Surgical
Unit (ISUTM)1 that is designed to enable machine vision
capabilities on the SenhanceⓇ Surgical System.
“TransEnterix is the first company to seek FDA clearance for
machine vision technology in abdominal robotic surgery. Rather than
simply passing a video signal to the surgeon, the Intelligent
Surgical Unit for Senhance will initially have the ability to
actually visualize the surgical field to guide movement and capture
information,” said Anthony Fernando, TransEnterix president and
CEO. “This technology advance is an important first step towards
enabling augmented intelligence and we believe it will support
continued machine vision driven advances in surgery performed with
the Senhance Digital Laparoscopy Platform."
The initial features of the Intelligent Surgical Unit (ISU) are
designed to increase control in visualization beyond what has
previously been available in digital laparoscopy or robotic
surgery. The cleared Senhance System already features unique
eye-tracking camera control and the new technology would 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. The ISU hardware is also designed
to be compatible with planned future augmented intelligence
features such as scene cognition and surgical image analytics that
are expected to continue to drive meaningful innovations in digital
laparoscopy with Senhance.
“Many of us that perform and teach surgery firmly believe that
the care of patients will be transformed by augmented intelligence
and machine vision capabilities in the future,” said Dr. Amit
Trivedi, chair of surgery at Hackensack Meridian Health Pascack
Valley Medical Center and a participant in the design and usability
studies conducted in support of the 510(k) submission of the ISU.
“Imagine if a computer could be the best assistant you’ve ever had
in surgery by anticipating and moving a camera effortlessly to
maximize control of the visual field. I’m very excited about this
new addition to the Senhance System.”
This Intelligent Surgical Unit will be compatible with the
global installed base of Senhance Surgical Systems, and will be
compatible with third-party vision systems that are currently
supported by Senhance.
Senhance Indication for use
In the U.S., The Senhance® Surgical System is intended to assist
in the accurate control of laparoscopic instruments for
visualization and endoscopic manipulation of tissue including
grasping, cutting, blunt and sharp dissection, approximation,
ligation, electrocautery, suturing, mobilization and retraction.
The Senhance Surgical System is intended for use in laparoscopic
gynecological surgery, colorectal surgery, cholecystectomy, and
inguinal hernia repair. The system is indicated for adult use. It
is intended for use by trained physicians in an operating room
environment in accordance with the Instructions for Use. The device
is restricted to sale by or on the order of a physician.
About TransEnterix
TransEnterix is a medical device company that is digitizing the
interface between the surgeon and the patient to improve minimally
invasive surgery by addressing the clinical and economic challenges
associated with current laparoscopic and robotic options in today's
value-based healthcare environment. The Company is focused on the
commercialization of the Senhance System, which digitizes
laparoscopic minimally invasive surgery. The system allows for
robotic precision, haptic feedback, surgeon camera control via eye
sensing and improved ergonomics while offering responsible
economics. The Senhance System is available for sale in the US, the
EU, Japan and select other countries. For more information, visit
www.transenterix.com.
Forward-Looking Statements
This press release includes statements relating to the Senhance
System and the Company’s 510(k) submission with an Intelligent
Surgical Unit that is designed to enable machine vision
capabilities on the Senhance Surgical System. 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 FDA will clear TransEnterix’s
510(k) submission; whether the 510(k) submission will support
continued machine vision driven advances in surgery performed with
the Senhance Digital Laparoscopy Platform; and whether the ISU
hardware with planned future augmented intelligence features will
continue to drive meaningful innovations in digital laparoscopy
with Senhance. For a discussion of the risks and uncertainties
associated with TransEnterix'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, 2018,
filed with the SEC on February 27, 2019 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.
1Pending 510(k), not available for sale within the United
States.
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version on businesswire.com: https://www.businesswire.com/news/home/20200114005251/en/
Investor Contact: Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media Contact: Terri Clevenger, +1 203-682-8297
terri.clevenger@icrinc.com
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