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Re: Daktari post# 16811

Saturday, 11/15/2014 12:35:34 PM

Saturday, November 15, 2014 12:35:34 PM

Post# of 140538
If you look back in one of my posts last week I mentioned that intuitive did not need to do human clinical trials on their new SP. They were able to use their original SP device, mostly the software as a predicate. They only were required to do bench trials, cadavers, human factor modeling, and porcine surgeries. What I am not sure is would FDA look at Titans software as needing further evaluation in human trials to verify safety, etc. Let's hope not. That could significantly move up the timelines.

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