TransEnterix (NYSE:TRXC) last week won the dismissal of a shareholders lawsuit brought over the collapse of its SurgiBot program, with a federal judge ruling that the company and its management and investors didn’t mislead shareholders about the robot-assisted surgery platform’s prospects with the FDA.
The case dates back to the spring of 2016, when Research Triangle Park, N.C.-based TransEnterix’s shares plunged after it revealed that the FDA denied its 510(k) application for SurgiBot, saying that the platform didn’t meet the criteria for substantial equivalence. The company soon shelved SurgiBot and turned to the already-CE-Marked ALF-X device it bought in a $100 million deal with Italy’s Sofar last year.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.