Medical devices are not drugs. They do not follow the same regulations. And in Europe the medical device registration can be very fast depending on the type of medical device (they have standard classifications for fast review, and some are self-certification type of registration).
You should never make a parallel between medical devices and drugs because those are just two very different markets. And unless you have a better source for your first point, I stand by my position that the US gets most of the approval first, worldwide. And most of the large pharma industries are American.