Asensus Surgical Receives CE Mark for Expanded Machine Vision Capabilities
23 Janvier 2023 - 12:55PM
GlobeNewswire Inc.
Asensus Surgical, Inc. (NYSE American: ASXC), a medical device
company that is digitizing the interface between the surgeon and
the patient to pioneer a new era of Performance-Guided Surgery™,
today announced receipt of CE Mark for an expansion of machine
vision capabilities on the previously cleared Intelligent Surgical
Unit™ (ISU™). With this CE Marking, the expanded ISU capabilities
are now commercially available across all of the Company’s key
geographies, including the European Union, Japan, and the U.S. In
addition, this approval included a review of the Senhance® Surgical
System platform, making Senhance one of the first robotic surgical
systems to be approved through the new, more rigorous EU Medical
Device Regulation, or MDR, process.
“We are thrilled to be able to offer these ground-breaking ISU
capabilities to surgeons in the EU. Surgeon feedback from the
expanded feature set across the U.S. and Japan has been tremendous,
and we look forward to partnering with new and existing customers
to help bring advanced real-time intraoperative digital tools into
operating rooms throughout Europe,” said Anthony Fernando, Asensus
Surgical President and CEO. “This is a significant milestone for
the Company as our filing included a review of the Senhance
Surgical System, both software and hardware, under the new,
stricter EU MDR process. The fact that Senhance was one of the
first robotic platforms to be cleared through the new process, in
just under one year, is a testament to both the quality of our team
and our technology.”
The Senhance Surgical System is powered by the
Intelligent Surgical Unit, enabling real-time surgical image
analytics and machine vision-driven control of the camera.
The newest ISU features introduce more advanced features
including: 3D measurement, digital tagging, image enhancement, and
enhanced intraoperative camera control based on real-time data.
“I have used the first generation of the ISU with the Senhance
Surgical System which seamlessly supports human-machine interaction
and endoscopic camera control. This second generation of ISU
features will bring surgeon support to a new level,” said Prof.
(Saitama Med. Univ.) Dr. med. Dietmar Stephan of St.
Marien-krankenhaus Siegen in Germany. The real-time measurement
tools have broad applicability in surgery, and digital tagging will
support communication between console and tableside indicating
critical structures, e.g. clipping points or staple lines. With
these new ISU features, I expect that the Senhance Surgical System
will be a technology leader in the field of augmented intelligence
in surgical robotics."
The approval 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 clinical intelligence for surgeons 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.
Follow Asensus
Email Alerts: https://ir.asensus.com/email-alerts
LinkedIn:
https://www.linkedin.com/company/asensus-surgical-inc
Twitter: https://twitter.com/AsensusSurgical
YouTube: https://www.youtube.com/c/transenterix
Vimeo: https://vimeo.com/asxc
TikTok: https://www.tiktok.com/@asensus_surgical
Forward-Looking Statements
This press release includes statements relating to the Senhance
Surgical System and the receipt of CE Mark for an expansion of
machine vision capabilities on the ISU. 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 we will be able to partner with new and existing
customers to help bring advanced real-time intraoperative digital
tools into operating rooms throughout Europe; whether the second
generation of ISU features will bring surgeon support to a new
level; whether digital tagging will support communication between
console and tableside indicating critical structures; whether with
the new ISU features, the Senhance Surgical System will be a
technology leader in the field of augmented intelligence in
surgical robotics; whether the additional features of the ISU will
provide meaningful support for surgeons across a range of
specialties and procedures and whether the foundational elements of
these features will enable Asensus to continue introducing novel
augmented intelligence features in the future by leveraging the
vast capabilities and potential of the ISU. 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, 2021, filed with the SEC on February 28,
2022 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.
INVESTOR CONTACT:Mark Klausner or Mike Vallie,
443-213-0499invest@asensus.com
MEDIA CONTACT:Isabella Rodriguez,
708-833-1572CG Lifeirodriguez@cglife.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/83d402f8-faea-499e-984e-3b3580281688
Asensus Surgical (AMEX:ASXC)
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