Titan Medical Inc (TMDIF)

[66Mustang]

Trixie's SurgiBot failure at FDA was due in part because the FDA had just issued new guidelines for Human Factors Engineering. My understanding is that the SurgiBot design was an older design and they were so far along in the process that they didn't want to take the schedule hit going back to the drawing board so they hoped they could ram it through approval with an AI. The FDA isn't that forgiving about organizations intentionally trying to circumvent their regulations. I had also heard that the FDA did not feel it was in fact a "substantially equivalent" product to da Vinci in its form at that time.

Titan has worked with the FDA and planned to continue to do so (I haven't heard any recent updates on that front) to ensure they were on the right track. FDA has a program fro early cooperation of some sort; I don't know if Titan is in that program or just sharing communications to ensure they remain on the right track and should sail through fairly easily. And I don't think anyone will question "substantial equivalence" of SPORT, as its capabilities seem to exceed da Vinci's, by all early reports.