Here's Why Shares Of TranEnterix Plunged 50% On Thursday

Shares of TransEnterix Inc TRXC, a medical device company that focuses on the development of a robotic assisted surgical system called SurgiBot System, plunged 50 percent on Thursday. TransEnterix announced that the U.S. Food and Drug Administration (FDA) notified the company on April 17 that its SurgiBot System does not meet the criteria for substantial equivalence based upon the data and information submitted by TransEnterix in its 510(k) submission. "The FDA's decision is extremely disappointing. We are in the process of reviewing all aspects of the FDA's communication," said Todd M. Pope, President and CEO of TransEnterix. "We will work to complete this review, and will provide an update on the regulatory strategy for the SurgiBot System together with our first quarter 2016 financial and operating results during our quarterly conference call on May 10, 2016."