Asensus Surgical Receives FDA 510(k) Clearance for Articulating Instruments
Instrument platform expected to expand dexterity and add capability to Senhance® Surgical System
RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–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 FDA 510(k) clearance for 5 mm diameter articulating instruments, adding to the Senhance Surgical System technology platform. Articulating instruments offer better access to difficult-to-reach areas of the anatomy by providing two additional degrees of freedom. These instruments have previously received CE Mark for use in the European Union.
“Bringing the benefits of 5 mm articulating instruments to the Senhance Surgical System in the U.S. will widen the clinical utility and value of our platform,” said Anthony Fernando, Asensus Surgical President and CEO. “Combining articulation and haptics with augmented intelligence is a very promising development for Performance-Guided Surgery.”
Asensus Surgical’s technology platform, the Senhance Surgical System, is the first of its kind digital laparoscopic platform that leverages augmented intelligence to provide unmatched performance and patient outcomes through machine learning. Senhance goes beyond the typical surgical robotic systems, providing surgical assurance through haptic feedback, eye-tracking camera control, and 3D visualization, and is the first platform to offer 3 mm instruments. Articulating instruments are the latest addition to the Senhance Surgical System in the United States, further enhancing surgical performance with robotic precision.
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. 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.
This press release includes statements relating to the Senhance Surgical System and the FDA 510(k) clearance for articulating instruments. 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 benefits of 5 mm articulating instruments to the Senhance Surgical System will widen clinical utility and value of our platform, and whether articulating instruments will expand dexterity and add capabilities to the Senhance Surgical System . 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.