TransEnterix (NYSE:TRXC) said today that the FDA responded to the 510(k) application for its robotic surgery SurgiBot system, saying that the platform does not meet the criteria for substantial equivalence based on the data and information in the application.
Research Triangle Park, N.C.-based TransEnterix claims SurgiBot as the 1st patient-side robotically enhanced laparoscopy platform, designed to be wheeled to a patient’s bedside and operate through a single port.
“The FDA’s decision is extremely disappointing. We are in the process of reviewing all aspects of the FDA’s communication. We will work to complete this review, and will provide an update on the regulatory strategy for the SurgiBot System together with our 1st quarter 2016 financial and operating results during our quarterly conference call on May 10, 2016,” CEO Todd Pope said in prepared remarks.
In March, TransEnterix said the FDA wasn’t finished reviewing the 510(k) application for its SurgiBot robot-assisted surgery device, pushing the decision it had expected to come during the 1st quarter back to mid-April.
In February, TransEnterix saw shares surge on speculation that the robot-assisted surgery company could be acquired by Johnson & Johnson (NYSE:JNJ), after J&J chairman & CEO Alex Gorsky said the healthcare conglomerate is back in the acquisition game now that valuations have come down. That fueled speculation that TransEnterix could be in J&J’s sights, even though the company is already in bed with Google‘s (NSDQ:GOOG) Verily Life Sciences to form robotic surgical venture Verb Surgical.
TransEnterix is battling with Titan Medical (CVE:TMD) in the race to challenge robot-assisted surgery’s dominant player, Intuitive Surgical (NSDQ:ISRG), and its da Vinci system. Titan is anticipating a mid-2017 debut for its Sport offering.
The post FDA: TransEnterix Surgibot 510(k) does not meet criteria for “substantial equivalence” appeared first on MassDevice.
from MassDevice http://ift.tt/1VHUhNG
Cap comentari:
Publica un comentari a l'entrada