TransEnterix (NYSE MKT:TRXC) has received an update from the FDA on the status of the 510(k) submission for its robotics SurgiBot system to improve minimally invasive surgery.
The FDA advised the company that it has not yet concluded the review of the 510(k) submission and provided an update on the status of the filing.
As a result, TransEnterix has updated its timing expectations and now expects to receive a decision from the FDA by mid-April, 2016. The company has previously expected a decision from the FDA in the first quarter this year.
“We have been engaged in constructive dialogue with the FDA throughout the entire submission process,” Todd Pope, president and CEO, said in a statement. “We appreciate the proactive exchange with the FDA and look forward to their decision, and continue to expect clearance for the SurgiBot,” he added.