TransEnterix (NYSE:TRXC) said last week that it won 510(k) clearance from the FDA for its Senhance robot-assisted surgery platform.
TransEnterix, which acquired Senhance for $100 million in September 2015, finalized its clearance bid last month after applying in April.
“The clearance of the Senhance system in the U.S. 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,” president & CEO Todd Pope said in prepared remarks. “Millions of surgical procedures in the U.S. are performed each year laparoscopically with basic manual tools that limit surgeons’ capability, comfort and control. New choices are needed that enhance the senses, control and comfort of the surgeon, minimize the invasiveness of surgery for the patient, and maximize value for the hospital. Senhance is this new choice.”
“Surgeons are approaching the boundaries of minimally invasive care performed with handheld manual instruments and cameras, and are seeking new technologies that will allow us to advance beyond these boundaries,” added Dr. Steve Eubanks of Orlando’s Florida Hospital. “The future will be driven by the appropriate use of robotics and information tools in the operating room. The Senhance platform grants laparoscopic surgeons robotic precision, control of our vision, and haptic feedback while minimizing procedural costs, and is a welcome revolution in our field.”
Morrisville, N.C.-based TransEnterix touts the system as the first new entrant into the robot-assisted abdominal surgery space since 2000, when Intuitive Surgical (NSDQ:ISRG) hit the market with the da Vinci platform. Senhance features haptic feedback and eye-sensing camera control.
Just last week the company escaped a shareholders lawsuit brought after it shelved its flagship SurgiBot last year, prompted by the FDA’s denial of its submission for 510(k) clearance.
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