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TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery

March 19, 2020

TransEnterix Surgical Unit

TransEnterix, Inc., a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced the Company received 510(k) clearance for the Intelligent Surgical Unit (ISUTM) that enables machine vision capabilities on the Senhance Surgical System.

TransEnterix Surgical Unit

“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. “Our system is designed to significantly advance the sensing capabilities of computer-assisted surgery. 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.”

The ISU enables machine vision driven control of the camera for a surgeon by responding to commands and recognizing certain objects and locations in the surgical field. The ISU hardware is also designed to be compatible with planned future augmented intelligence features such as scene cognition and surgical image analytics that are expected to continue to drive meaningful innovations in digital laparoscopy with Senhance.

“This is the beginning of a new era in digital surgery,” said Dr. Amit Trivedi, chair of surgery at Hackensack Meridian Health Pascack Valley Medical Center and a participant in the design and usability studies conducted in support of the 510(k) submission of the ISU. “Surgery is the skilled real time application of vision, experience, precise motion and decision making. The opportunity to use a computer to see aspects of the field and guide surgery is enormous. I am eager to utilize machine vision to better control the camera seamlessly during my surgeries.”

See Full Press Release: TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery


Written by: TransEnterix


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