TransEnterix receives FDA 510(k) clearance for first machine vision system in robotic surgery.

TransEnterix announced that it received FDA 510(k) clearance for its Intelligent Surgical Unit (ISU), a system that enables machine vision capabilities on the company’s Senhance Surgical System. According to the company, the ISU allows surgeons to better control the laparoscopic camera by responding to commands and recognizing certain objects and locations in the surgical field. It is also compatible with planned scene cognition and surgical image analytics features. The ISU is used with the Senhance Surgical System, which is currently indicated for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The platform features haptic feedback, minimal docking time, and surgeon-controlled camera movements. Senhance is a rare competitor to Intuitive Surgical’s da Vinci robotically-assisted surgical system. TransEnterix claims several key advantages, such as head- and eye-tracking technology that allows the surgeon to move the laparascopic camera with minimal workflow interruption, and reusable instruments that significantly decrease cost.