The medical device company TransEnterix (NYSEAMERICAN:TRXC) is on the receiving end of good news from the US Food and Drug Administration which has awarded 510(k) clearance for its 3 millimeter as well as additional 5 millimeter Senhance system instruments.
The FDA’s clearance of the 3 millimeter diameter instruments will pave the way for the company’s Senhance robotic surgery system to be used for microlaparoscopic surgeries that enable surgeons to operate through tiny incisions that don’t leave patients with severe scarring.
Investors also welcomed the FDA’s move, sending Transenterix shares up 13% to $5.06 before Thursday’s opening bell.
Todd Pope, CEO of TransEnterix, said the FDA’s acceptance of its 3 millimeter instruments represents an “unparalleled shift” in robotic surgery.
“The addition of 3 millimeter instruments will allow many high volume surgeries to be performed with smaller incisions, which supports our mission of advancing minimally invasive surgical capabilities within digital laparoscopy,” Pope said in a statement.
Based in Morrisville, North Carolina, TransEnterix is a pioneer in the use of robotics to advance minimally-invasive surgery.
Contact Ellen Kelleher at [email protected]