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IET

Re: samiam1862 post# 36305

Thursday, 04/21/2016 10:37:55 AM

Thursday, April 21, 2016 10:37:55 AM

Post# of 140467
I'm not worried there. Don't forget equivalence refers to both operation and safety. It has already been known for a while that the FDA is not happy with how this space is developing, and increasingly concerned about patient safety. In terms of operation, obviously the Surgibot does not operate as Da Vinci. It's not even a robot. In terms of safety, I'll leave that to the surgeons out here to assess, and the comments already received on how difficult it was to move that thing around with the kid toy knobs.

In my opinion, the FDA just put the breaks on a company they considered the worst offender on both these points as a warning to all in the industry, but I do not think this will affect Titan, or is in any way directed at them.

Titan has a very highly qualified professional board, and Fowler at the foreground of patient safety in surgical robotics nationwide. Safety has always been the highest priority. In terms of operation, SPORT is not only equivalent. There is a strong case it will perform better.

This is why Titan has the FDAs respect and why they wanted input from them. In fact, such input from respectable companies is probably exactly why TRXC did not receive approval. The company is dead, gone, bye bye LTG...you were dead wrong.