TransEnterix Submits 510(k) to FDA for First Machine Vision System in Robotic Surgery

Posted on January 14, 2020 by Medtech[y] Staff

TransEnterix (NYSE: TRXC) is up more than 50% in early trading as the company announced that they've filed a 510(k) submission with an Intelligent Surgical Unit (ISUTM) that is designed to enable machine vision capabilities on the Senhance Surgical System.

This news comes on the heels of partnership agreement with Oschner Health System, where one of their facilities will be leasing a Senhance Surgical System.

While details are scarce of what the machine vision technology will look like, the company did say that the Intelligent Surgical Unit will be compatible with the global installed base of Senhance Surgical Systems, and will be compatible with third-party vision systems that are currently supported by Senhance.

TransEnterix President and CEO, Anthony Fernando, said, "TransEnterix is the first company to seek FDA clearance for machine vision technology in abdominal robotic surgery. Rather than simply passing a video signal to the surgeon, the Intelligent Surgical Unit for Senhance will initially have the ability to actually visualize the surgical field to guide movement and capture information.”

Fernando continued, “This technology advance is an important first step towards enabling augmented intelligence and we believe it will support continued machine vision driven advances in surgery performed with the Senhance Digital Laparoscopy Platform."

While the Senhance System already features eye-tracking camera control, the initial features of the Intelligent Surgical Unit (ISU) are designed to increase control in visualization beyond what has previously been available in digital laparoscopy or robotic surgery.

The new technology would enable 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.

“Many of us that perform and teach surgery firmly believe that the care of patients will be transformed by augmented intelligence and machine vision capabilities in the future,” 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. “Imagine if a computer could be the best assistant you’ve ever had in surgery by anticipating and moving a camera effortlessly to maximize control of the visual field. I’m very excited about this new addition to the Senhance System.”