Asensus Surgical Announces FDA Clearance in General Surgery
Indications Expand to Include New Procedures in Large General Surgery Market
Asensus Surgical's technology platform, 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 (the smallest instrument available in the world on a robotic surgical platform).
“The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology,” said
“Many of the procedures we perform in general surgery require complex reconstruction throughout a wide surgical field,” said Dr.
Senhance US Indication for Use
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 general laparoscopic surgical procedures and laparoscopic gynecological surgery. 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.
This press release includes statements relating to the Senhance Surgical System and the FDA clearance to allow for a US indication in general surgery. 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 expansion into general surgery for the Senhance Surgical System will be a major milestone for the growth and clinical applicability of the Company’s technology. For a discussion of the risks and uncertainties associated with the Company’s business, please review our filings with the