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TransEnterix Inc.

TransEnterix Announces Sinai Health System in Chicago to Initiate Program with the Senhance Surgical System

“Our team is excited that Sinai Health System has chosen to add the Senhance Digital Laparoscopy Platform to its minimally invasive surgery program,” said Anthony Fernando, president and chief executive officer at TransEnterix. “In the midst of the challenging times posed by COVID-19, hospitals are looking to the future and continue to seek more advanced and cost-effective technologies to treat their patients undergoing surgery. We are thrilled to partner with the excellent surgical team at Sinai Health System.”

TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery

This Intelligent Surgical Unit is compatible with both the global installed base of Senhance Surgical Systems and with third-party vision systems that are currently supported by Senhance.

Kitakyushu General Hospital Completes First Surgical Procedures with the Senhance Surgical System

Kitakyushu General Hospital, a hospital in southwestern Japan, completed its first surgical procedures using the Senhance® Surgical System. The first patients were treated by Dr. Naoki Nagata, President of Kitakyushu General Hospital, and team across general and colorectal minimally invasive surgical procedures. TransEnterix had announced on January 29, 2020 that Kitakyushu General Hospital had entered into an agreement to lease and utilize a Senhance System.

Broad Reimbursement Approval in Japan for Senhance Digital Laparoscopy System

The reimbursement, which became effective on July 31, 2019, applies to 98 benign and malignant laparoscopic procedures across general, colorectal, gynecologic, bariatric and urologic surgeries at reimbursement rates equivalent to traditional laparoscopy in Category A1. The Senhance received regulatory approval from the Japanese MHLW on May 22, 2019.

TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments

10/11/18: The clearance of the 3 millimeter diameter instruments will allow the Senhance to be used for microlaparoscopic surgeries, enabling surgeons to operate through tiny incisions considered virtually scarless for patients.

TransEnterix Receives CE Mark Approval for Senhance Ultrasonic Instrument System

10/1/18: “Advanced energy devices are an important tool for laparoscopic surgeons because of their applicability within a wide range of procedures,” said Todd M. Pope, TransEnterix CEO. “We believe the addition of the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries that accept CE Mark around the world.”

TransEnterix Announces FDA 510(k) Submission for 3mm Senhance Instruments

6/8/18: “TransEnterix is the first company to seek FDA clearance for robotically-driven 3 millimeter instruments for abdominal surgery in the U.S.,” said Todd M. Pope, TransEnterix CEO. “We believe Senhance robotic assistance can enable surgeons to expand their use of virtually scarless surgery in more patients, and expands the value that robotics can bring over traditional manual approaches."

TransEnterix Announces FDA 510(k) Submission for Senhance Indication Expansion to More than Double Addressable Market in the U.S. and Provides Commercial Update

TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced the Company has filed a FDA 510(k) submission to expand the indication for use of its Senhance™ Surgical System, and provided an update about commercial results thus far for the quarter ending March 31, 2018.