FDA rejects TransEnterix's SurgiBot marketing application; shares down 54%

• TransEnterix (TRXC -54.2%) plummets on a 6x surge in volume in response to its announcement that the FDA has rejected its 510(k) application seeking clearance of its SurgiBot System. Under the 510(k) process, a company only has to demonstrate substantial equivalence to a product that is already cleared for sale in the U.S.
• The company will update investors on the situation during its earnings call on May 10 after the close.