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Home>TransEnterix, Inc. Reports Progress on Senhance FDA Submission

TransEnterix, Inc. Reports Progress on Senhance FDA Submission

TransEnterix, Inc. Reports Progress on Senhance FDA Submission

09/18/2017

TransEnterix, Inc. Reports Progress on Senhance FDA Submission

- Files additional information response with FDA -

- Continues to expect 510(k) clearance in 2017 -

TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, today announced the Company has filed its response to the Food and Drug Administration’s (“FDA”) Additional Information (“AI”) request related to the Company’s Senhance Surgical Robotic System 510(k) submission.

“We are very pleased to have submitted our AI response ahead of schedule, demonstrating our team’s effectiveness and our ongoing collaboration with the FDA,” said Todd M. Pope, President and Chief Executive Officer of TransEnterix. “The submission of our response is a key step towards achieving 510(k) clearance for the Senhance, which we continue to expect in 2017.”

About TransEnterix

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The Company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States. For more information, visit the TransEnterix website at www.transenterix.com.

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