TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery
13 Marzo 2020 - 4:55AM
Business Wire
The Intelligent Surgical Unit Enables Augmented
Intelligence on 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 received 510(k) clearance for the Intelligent Surgical
Unit (ISUTM) that enables machine vision capabilities on the
SenhanceⓇ Surgical System.
“We are pleased to have received this important clearance
earlier than expected. Machine vision is the next major advance in
digital surgery,” said Anthony Fernando, TransEnterix president and
CEO. “Our system is designed to significantly advance the sensing
capabilities of computer-assisted surgery. With this hardware and
software system, the Senhance System will gather and interpret
visual information from the surgical field. The capabilities now
cleared will be focused on optimizing visualization and camera
control in ways never before offered in robotic or digital surgery.
These initial capabilities represent the first step in our journey
to bring the benefits of augmented intelligence and machine vision
to surgery."
The ISU enables 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.
“This is the beginning of a new era in digital surgery,” 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. “Surgery is the skilled real time application of vision,
experience, precise motion and decision making. The opportunity to
use a computer to see aspects of the field and guide surgery is
enormous. I am eager to utilize machine vision to better control
the camera seamlessly during my surgeries.”
This Intelligent Surgical Unit is compatible with both the
global installed base of Senhance Surgical Systems and 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.
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
market development activities for, and increasing utilization of,
its Senhance Surgical 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 Surgical 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) clearance of its 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 Intelligent Surgical Unit will
be focused on optimizing visualization and camera control in ways
never before offered in robotic or digital surgery; and whether the
ISU is the beginning of a new era in digital surgery. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200313005044/en/
For TransEnterix, Inc. 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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