Replies to post #4299 on Titan Medical Inc (TMDIF)

[investinthefuture]

I agree, the fact Titan has been able to stay on schedule is promising. Cross your fingers that it continues. I am a pharmaceutical clinical trials monitor. In drug research & development it is very rare to stay within an initial project timeline. I love the optimism from the posters on this board. I certainly hope the FDA isn't as "bi-polar" with medical device approvals as it is with INDs!

The 510(k) clearance is totally different than drug trials. While drug approval requires extensive human clinical trials and a thumbs up/down from the FDA based on the efficacy of the drug, device clearances are much more of a formality (unless the device is a radiological device or an entirely new device category). As long as Titan can essentially demonstrate that SPORT is an evolution of the existing surgical robot, then the 510(k) clearance should go smoothly and quickly next year.