That was before the problem with contaminated Olympus endoscopes because of improper cleaning procedures after design changes.
It wouldn't be too surprising if there are more stringent evaluations in the wake of that, so the external sheath is a very critical component. I suspect that's why it took so long for them to get the design right, but I would expect close scrutiny from the FDA. No doubt in my mind though that it will pass.
That was before the problem with contaminated Olympus endoscopes...
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