TransEnterix (NYSE:TRXC) said yesterday that it submitted an application for 510(k) clearance from the FDA for its SurgiBot robot-assisted surgery device.
Research Triangle Park, N.C.-based TransEnterix claims the SurgiBot as the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s bedside.
"TransEnterix is pleased to deliver on our commitment to file for 510(k) clearance for the SurgiBot system by mid-2015. Robotically enhanced laparoscopy with the SurgiBot system represents the 1st surgical platform designed to address economic and clinical challenges associated with current laparoscopic and robotic options. We view the SurgiBot as a market-expanding technology with a compelling value for a wide variety of surgical facilities with the potential to deliver critical benefits to surgeons, hospitals and patients. We look forward to continuing our preparation to bring this innovative technology to the market upon FDA clearance," CEO Todd Pope said in a press release.
Piper Jaffray analyst Matt O’Brien predicted that TransEnterix will hit the U.S. market in early 2016, having a modest impact on Intuitive Surgical (NSDQ:ISRG), the largest player in the robot-assisted surgery space. SurgiBot will do more to expand the market rather than take share from Intuitive, O’Brien wrote in a note to investors.
TransEnterix in 2013 merged with SafeStitch Medical, which later took the company’s name and combined stock for both companies.