FDA OKs Asensus’ Senhance for General Surgery

Asensus Surgical (formerly TransEnterix) has received an additional FDA clearance for the Senhance Surgical System that has expanded its indication to general surgery in the U.S.
 
Senhance is a first-of-its-kind digital laparoscopic platform that leverages augmented intelligence to boost performance and patient outcomes via machine learning. It goes beyond typical surgical robotic systems, offering surgical assurance through haptic feedback, eye-tracking camera control, and 3D visualization. Senhance is the first platform to offer 3 mm instruments—the smallest instrument available on a robotic surgical platform, according to Asensus.
 
“The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology,” Asensus president and CEO Anthony Fernando said in a press 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 US annually.”
 
“Many of the procedures we perform in general surgery require complex reconstruction throughout a wide surgical field,” added Dr. Sabino Zani, Assistant Professor of Surgery at Duke University and an investigator in the clinical studies submitted for indication expansion. “Senhance can now be seen as a widely applicable tool for general surgeons across the broad range of procedures that may be performed from deep in the pelvis to the upper abdomen.”