The FDA has advised TransEnterix (NYSE MKT:TRXC) that its SurgiBot System does not meet the criteria for substantial equivalence based on the data and information submitted by the company 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,” Todd Pope, president and CEO, said in a statement.
“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,” he added.
SurgiBot is a single-port, robotically enhanced laparoscopic surgical platform.