Yeah, I was a bio med engineer at Case. Wired up quadriplegics for direct neural stimulation for my graduation project. I worked at the Cleveland Clinic doing LVAD controllers. Earlier, I did several years in the OR as a tech (scrub nurse), and then set up and ran an electrophysioligy lab for ophthalmology for a year and a half.
That said, it is hard to imagine how difficult it is to get a new device certified for use even if it is not invasive. New is generally resisted by big money unless they own it. It might be possible in a civilized country, but here? In Cleveland, the Cleveland Clinic and University Hospitals have a virtual monopoly on this kind of thing. And they have the bucks to insure that nobody goes up against them.