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FDA clears digital surgical system for hernia, gallbladder surgeries
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The FDA has added laparoscopic inguinal hernia surgery and laparoscopic cholecystectomy to the approved procedures for the Senhance Surgical System.
According to the manufacturer, TransEnterix, the computer controlled surgical system designed to improve minimally invasive surgeries can now be used for some of the most common abdominal surgeries.
“This indication expansion immediately doubles the addressable market for Senhance in the U.S. and validates our regulatory strategy to successfully add to our indications for use,” Todd M. Pope, president and CEO of TransEnterix, said in a press release. “These expanded procedures are commonly performed at over 95% of hospitals in the United States. We believe this indication expansion will significantly increase the applicability of Senhance to more institutions, particularly those with a busy general surgery practice.”
The Senhance system gives surgeons robotic precision and haptic feedback, and control of the system’s camera through eye-sensing technology, according to the press release.
The FDA has already cleared the device for laparoscopic colorectal and gynecological procedures.
Disclosures: Pope is employed by TransEnterix.