JPM: TransEnterix submits digital vision surgery assistant for FDA review

SAN FRANCISCO—Robotic surgery company TransEnterix has put up its machine vision system for review by the FDA with the goal of providing a personal digital assistant for surgeons during abdominal procedures.  

The 510(k) submission covers the company’s Intelligent Surgical Unit as an add-on to its previously cleared Senhance laparoscopic surgical system. To start, the machine vision capabilities will aim to augment the surgeon’s control of the camera during a procedure by using a combination of operator commands, the Senhance system’s eye-tracking features and by recognizing certain objects and locations in the surgeon’s field of view.

The hardware is also designed to enable planned features, such as scene cognition and surgical image analytics for digital laparoscopy, according to TransEnterix.

Pending approval, “we will be the first company to offer these technologies on a robotic platform,” CEO Anthony Fernando said in an interview at the annual J.P. Morgan Healthcare Conference. 

“Surgeons are super excited, because this is the first time that they’re beginning to see the makings of a dependable, reliable, digital assistant that’s there every day,” Fernando said. “This assistant can learn how the surgeon approaches their cases and help standardize those methods.”

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By tracking information such as the instruments being used, the organs involved and characteristics of the patient, the system can anticipate what the surgeon will want to see during the procedure. 

“And it will learn—say, ‘Okay, this surgeon, with this BMI, always uses this approach, so maybe I’ll help the surgeon by zooming in or zooming out,’” he said. 

For the future, the machine vision assistant is being developed to help recognize when the surgeon is straying off course, compared to their previous procedures and techniques performed by other surgeons using the system. 

“Our goal is, in the long run, to be collecting all of this data,” Fernando said. “It’s not just the one surgeon. Now the surgeon can benefit from thousands of cases, done from all over, focused in that specific anatomy—and the system’s ability to tell the surgeon that, based on the global database, that here is an approach that you could try, even if it’s not what the surgeon is used to.”

The Intelligent Surgical Unit is designed to be compatible with the global installed base of Senhance systems and will be compatible with currently supported third-party vision systems, the company said.