Skip to main content

Market Overview

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

Share:

Shares of TransEnterix Inc (NYSE: 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."

 

Related Articles (TRXC)

View Comments and Join the Discussion!

Posted-In: Joseph Slattery Robotic Surgery SurgiBot System TransenterixNews FDA Movers

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
SPAC
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com