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TransEnterix submits 510(k) to FDA for Intelligent Surgical Unit

Wed, 01/29/2020 - 17:22
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TransEnterix has announced it has filed a 510(k) submission with an Intelligent Surgical Unit (ISU) that is designed to enable machine vision capabilities on the Senhance Surgical System. The initial features of the Intelligent Surgical Unit (ISU) are designed to increase control in visualisation beyond what has previously been available in digital laparoscopy or robotic surgery.

“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 maximise control of the visual field. I’m very excited about this new addition to the Senhance System.”

The approved Senhance System already features unique eye-tracking camera control and the new technology would enable machine vision driven control of the camera for a surgeon by responding to commands and recognising 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 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 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 visualise the surgical field to guide movement and capture information,” said Anthony Fernando, TransEnterix president and CEO. “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.”