TransEnterix wins FDA approval for expanded indications for Senhance Surgical System

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TransEnterix wins FDA approval for expanded indications for Senhance Surgical System

TransEnterix Inc. shares surged 12% in premarket trade Tuesday, after the company said it has won U.S. Food and Drug Administration approval for expanded indications for its Senhance Surgical System. Specifically, the company said the FDA has cleared the medical device company for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. “There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S.,” the company said. “With this clearance, Senhance System’s total addressable annual procedures in the U.S. has more than doubled to over three million.” Senhance is now approved for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgery. Shares have gained 566% in the last 12 months, while the S&P 500 has gained 13%.

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