TransEnterix Surgical Inc. this week announced that it has filed a 510(k) submission to the U.S. Food and Drug Administration for its Intelligent Surgical Unit, which is designed to enable machine vision capabilities for the Senhance system.

Morrisville, N.C.-based TransEnterix has been working to commercialize the Senhance system, which it said digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing, and improved ergonomics. Senhance is intended to be less expensive than other robotic surgery systems, and it is available for sale in the U.S., the EU, Japan, and other countries. The company planned to raise $20.3 million in a public stock offering last fall.

Machine vision to give surgeons ‘augmented intelligence’

“TransEnterix is the first company to seek FDA clearance for machine vision technology in abdominal robotic surgery,” stated Anthony Fernando, president and CEO of TransEnterix. “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.”

“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,” he added.

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 Senhance system, which has FDA clearance for certain procedures, already features unique eye-tracking camera control.

The new machine vision technology would respond to surgeon commands to the camera and recognize certain objects and locations in the surgical field. The ISU hardware is also designed to be compatible with planned “augmented intelligence” features for Senhance such as scene cognition and surgical image analytics, said TransEnterix.

“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.”

The ISU will be compatible with the global installed base of Senhance surgical systems, and it will be compatible with third-party vision systems that are currently supported by Senhance.

Senhance indication for use

In the U.S., the Senhance surgical system is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction.

Senhance is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The robotic-assisted surgical system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use. The robotic surgery device is restricted to sale by or on the order of a physician.