ISRG was not required to submit any live human clinical trial data on the new SP device for the xi to get 510k clearance. It used benchwork, cadaver and porcine models. It was able to use its original SP device as a predicate device.
This actually bodes very well for Titan only needing a 510K clearance. They need to give at least 90 days PMN before marketing their device in the US.
Geo, intuitive has already announced that they will not be releasing the new SP for the xi. Additionally, it carries a warning label indicating it is only cleared for urologic surgery.
If Titan can get a small jump on them with sport both in timing and clearance for general surgery that should positive.
I am guessing that both companies will be doing concurrent work to get clearances for additional specialties either at lunch or very closely after.
Intuitive already has the market cornered for urologic surgery so adding a SP device that can only do uro will be a difficult sell to hospitals.
It would also not increase marketshare for tightened.
In comes Titan Medical !!
BelizeMe
Market Data 
Markets 
AI
