Surgical technology platform receives additional FDA clearance

Asensus Surgical, a medical device company that is digitising the interface between the surgeon and patient in Performance-Guided Surgery has received additional FDA clearance for the Senhance Surgical System which allows for indication expansion in general surgery.

Asensus Surgical's technology platform, Senhance Surgical System, leverages augmented intelligence to improve patient outcomes through machine learning. It provides surgical assurance through haptic feedback, eye-tracking camera control, and 3D visualisation, and is the first platform to offer 3 mm instruments (the smallest instrument available in the world on a robotic surgical platform). 

Anthony Fernando, Asensus Surgical president and CEO, said: “The expansion into general surgery for the Senhance Surgical System is a major milestone for the growth and clinical applicability of our technology. 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 utilised in over 2.7 million general surgical procedures performed in the US annually."

Dr. Sabino Zani, assistant professor of surgery at Duke University and an investigator in the clinical studies submitted for indication expansion, said: “Many of the procedures we perform in general surgery require complex reconstruction throughout a wide surgical field. 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.” 

The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualisation and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilisation, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynaecological 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.