LONDON, UK / ACCESSWIRE / October 17, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for TransEnterix, Inc. (NYSE: TRXC), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=TRXC. The Company announced on October 14, 2017, that the US Food and Drug Administration (FDA) has granted US 510(k) clearance to TransEnterix's Senhance? Surgical Robotic System. As a result of the clearance, the Senhance? becomes the first new market entrant into the field of abdominal surgical robotics since 2000. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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Clearance of Senhance? System in the US is a Milestone in Progress of Robotics

Todd M. Pope, President and Chief Executive Officer (CEO) of TransEnterix, mentioned that the clearance of the Senhance? System in the US is a milestone in the progress of robotics and is expected to deliver improvement in the efficacy, value, and choices offered to patients, surgeons, and hospitals.

He added that millions of surgical procedures in the US are performed each year laparoscopically with basic manual tools that limit surgeons' capability, comfort, and control. New choices are needed to enhance the senses, control, and comfort of the surgeon, minimize the invasiveness of surgery for the patient, and maximize value for the hospital. Pope believes that Senhance? is the new choice.

Senhance? System is a Specialized Innovation in Minimally Invasive Surgery

Binita Ashar, M.D., Director of the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health, stated that minimally invasive surgery helps reduce pain, scarring, and recovery time after surgery. Senhance? System, a robotically-assisted surgical device (RASD) technology, is a specialized innovation in minimally invasive surgery designed to enhance the surgeon's access and visualization within confined operative sites.

TransEnterix Filed FDA 510(k) Application for Senhance? in April 2017

In April 2017, TransEnterix filed an application with the FDA seeking 510(k) clearance for its Senhance? robot-assisted surgery platform. In September 2017, the Company filed its response to FDA's Additional Information request related to the 510(k) submission.

Pilot Study of Senhance? Robotic Platform in Obese Patients

A pilot study was conducted by the Company aimed to value the feasibility and safety of Senhance? Robotic Platform for hysterectomy in obese patients. Ten obese patients with the average age of 60 years underwent elective Senhance? total extrafascial hysterectomy with bilateral salpingo-oophorectomy. Perioperative and postoperative outcomes data were recorded. The results concluded that the Senhance? platform could be safe for hysterectomy even in obese patients.

About Senhance? Surgical Robotic System

Senhance? Surgical Robotic System is 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 device is intended to be used for laparoscopic surgery in the abdomen and pelvis of adult human patients and endoscopic manipulation of tissue.

Senhance? utilizes an open architecture, which allows hospitals and surgeons to leverage existing technology investments within the operating room ecosystem. The system is specifically engineered to manage operative costs effectively, making robotic surgery cost-effective on a per-procedure basis through the use of fully reusable instruments. Senhance? is a trademark of TransEnterix.

About US 510(k) Clearance

A 510(k) notification is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

About TransEnterix, Inc.

Founded in 2005, 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 headquartered in Morrisville, North Carolina.

Last Close Stock Review

On Monday, October 16, 2017, the stock closed the trading session at $2.81, skyrocketing 92.47% from its previous closing price of $1.46. A total volume of 79.60 million shares have exchanged hands, which was higher than the 3-month average volume of 1.37 million shares. TransEnterix's stock price skyrocketed 89.86% in the last one month, 284.93% in the past three months, and 126.61% in the previous six months. Furthermore, since the start of the year, shares of the Company have soared 116.15%. The stock currently has a market cap of $420.15 million.

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