Titan Medical Inc. yesterday delayed the timeline for its submission to the U.S. Food and Drug Administration for clearance of its Sport robot-assisted surgical device. The Toronto-based company said it now expects to file and receive FDA approval next year.
With a successful human factors evaluation (HFE) of the single-port device under its belt, Titan Medical said it expects to file for an investigational device exemption (IDE) from the FDA in the fourth quarter. The full 510(k) filing is slated for the first half of 2020, not by the end of this year as previously expected, Titan said.
“We have now successfully completed all [good laboratory practice] and HFE studies, which have further demonstrated our single-port system’s best in-class potential,” stated CEO David McNally. “We will now take additional time to perfect our system and implement all planned system and sterile instrument interface components, software enhancements and training tools, in order not only to further de-risk our IDE studies, but also to introduce a more refined product in the marketplace.”
Examining funding, filing options for Sport
“By extending our resources and milestones, we can ensure the highest likelihood of success for our single-port robotic system from clinical, regulatory, and commercial perspectives, and enable a robust and careful examination of our future funding options, which may include strategic sources,” McNally added.
The Robot Report has launched the Healthcare Robotics Engineering Forum, which will be on Dec. 9-10 in Santa Clara, Calif. The conference and expo focuses on improving the design, development and manufacture of next-generation healthcare robots. Learn more about the Healthcare Robotics Engineering Forum.