Yes it was a big win for Titan when ISRG SP got FDA approval, as they did all the heavy lifting. Titan will need to prove predicate equivalent in order for the 510k to go through. I know Titan has been active with the FDA for a couple of years now, and when they file they are filing with feedback and guidance already from the FDA. The early dialogs and understanding of what they need to be doing to prepare for approval will pay off in the end - IMO.
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