The company expected a submission date in late 2018.
TITAN Medical Inc.(TSX:TMD) leadership today spoke on the future of the company and its Sport single-port robotic surgery platform, saying it expects to begin submission of clinical data in pursuit of FDA approval by 2019, up from a previously expected submission in late 2018, and that it is exploring eligibility for a cross listing on a US stock exchange.
CEO David McNally, head of the Toronto-based company, said Titan Medical has already begun its conversation with the FDA and that it met with a qualified European notified body for CE Mark approval as they set out in pursuit of regulatory clearance in both markets.
The FDA reportedly informed the company that it can pursue a 510(k) pathway for the system, but Titan said it is still looking to confirm the “most likely predicate devices that would lead to the least burdensome pathway for clearance to market,” according to McNally.
