I can answer part of your question.
I think the USFDA process is more stringent, more demanding. It's a class-based system, so depending on the level of risk associated with a technology, the requirements will be high or low. This might explain why there are different perspectives.
The FDA is more stringent, and most companies go to Europe first. The CE marking system is easier to pass through. It's a better way to get some revenue out of commercialization, and to then go to the FDA. The FDA is the big market, not Canada, so that's the way.