Transenterix Partially Recovers Early Morning Plunge Following FDA Update

Shares of Transenterix Inc TRXC were highly volatile on Monday after the company received an update from the U.S. Food and Drug Administration (FDA). Transenterix applied for a 510(k) submission with the FDA which would grant the company marketing clearance for its SurgiBot, a robotically enhanced laparoscopic surgical platform. Transenterix stated that the FDA has yet to conclude the review of its submission and expects to receive a decision from the FDA by mid-April. The company previously expected a decision from the FDA by the end of the first quarter of 2016. "We have been engaged in constructive dialogue with the FDA throughout the entire submission process," said Todd M. Pope, President and Chief Executive Officer of TransEnterix. "We appreciate the proactive exchange with the FDA and look forward to their decision, and continue to expect clearance for the SurgiBot."