TransEnterix Receives FDA Clearance for Intelligent Surgical Unit


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 touts 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.

“We are pleased to have received this important clearance earlier than expected. Machine vision is the next major advance in digital surgery,” said Anthony Fernando, TransEnterix president and CEO, in a statement. “With this hardware and software system, the Senhance System will gather and interpret visual information from the surgical field. The capabilities now cleared will be focused on optimizing visualization and camera control in ways never before offered in robotic or digital surgery. These initial capabilities represent the first step in our journey to bring the benefits of augmented intelligence and machine vision to surgery.”

Product page: Senhance

Via: TransEnterix

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