Asensus Surgical (NYSE:TRXC), formerly TransEnterix, announced that it won expanded FDA clearance for its Senhance surgical system.
Research Triangle Park, N.C.-based Asensus Surgical’s Senhance surgical system, which it touts as the first-of-its-kind digital laparoscopic platform that leverages augmented intelligence to provide strong performance and positive patient outcomes through machine learning, now has FDA clearance for indication expansion in general surgery, according to a news release.
The surgical robotic system provides assurance through haptic feedback, eye-tracking camera control and 3D visualization, while also being the first such platform offering 3mm instruments, which are the smallest available on a robotic surgical platform.
Senhance’s U.S. indication is for controlling laparoscopic instruments for visualization and endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction.
It is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery and only for adult use, while trained physicians must use it in an operating room environment in accordance with the instructions for use.
Expanded indication for Senhance follows last month’s news that the company would change its name from TransEnterix to Asnesus Surgical and introduce a new category of surgery. The company seeks to enter a new era of performance-guided surgery, as the company focuses on digitizing the interface between the surgeon and the patient to unlock clinical intelligence that may enable superior outcomes and potentially a new standard of surgery.
“The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology,” Asensus Surgical president & CEO Anthony Fernando said in the release. “General surgery is, by far, the largest area of manual laparoscopy which can benefit from the precision and insight of performance-guided surgery.
“The indication expansion allows Senhance to be used in many high-value, complex reconstructive surgeries such as those used to treat reflux and obesity. Including previous indications granted, the Senhance Surgical System can now be utilized in over 2.7 million general surgical procedures performed in the U.S. annually.”