Titan Medical (NSDQ:TMDI) said today that it expects to file for 510(k) clearance in the U.S. and CE Mark clearance in the E.U. by the end of 2019 for its Sport robotic surgical system.
The company added that based on the timing of the approvals, Titan plans to begin commercializing its single-port robotic system in 2020.
For the first half of 2019, Titan plans to finish verification and validation testing. The second half of the year will be focused on implementing its IDE study and filing its 510(k) submission, the company said.
“We are encouraged by the collaborative nature of our correspondence and conversations with the FDA, and are confident that with their guidance, our confirmatory studies will be designed and executed to meet their standards. Under the leadership of Curtis Jensen, our Vice President of Quality and Regulatory Affairs, and with expert guidance from trusted surgeon advisors, planning meetings have already been held with qualified hospitals in preparation for our IDE study,” president & CEO David McNally said in prepared remarks.
“Based on our close interaction with regulatory bodies in the U.S. and the EU during 2018, we believe we have a clear understanding of the requirements to support our respective regulatory submissions. In parallel with planning for our IDE study in the U.S., we are preparing to complete the necessary audit and required documentation for the CE mark. We are well positioned to execute on a sound regulatory plan for our initial target markets,” McNally added.
In February last year, Titan Medical announced it would push back its expected 510(k) submission date for the surgical system. Previously the company intended to submit for approval in late 2018.
