We tried it a couple of times, but it was always more serious than we were willing to invest into.
The great thing about our arrangement with the NHS was we gave them the IP, so they owned the app. They were also the only people using the app (the have an effective monopoly on emergency medicine in the UK), so if something went wrong it's the NHS using an NHS app and they could work it out themselves, and not companies suing companies.
I don't think that kind of simple arrangement would be possible in the US, but I don't know much about US healthcare apart from it isn't nationalised.
Yeah, it was difficult for me to see from the FDA's website how exactly you'd get approved. If you did have to go through De Novo or PMA then you're probably looking at years and years if you can even get the regulators to accept it. It's not like there's a predicate device for what you're doing so there's nothing you can point to. From what I understand, De Novo is where cool ideas go to die.
FDA protects people from a lot of bad devices, but it also makes it really difficult for people to innovate here. My last job was with a company doing a 510k and we were delayed 6 months while the branch of the FDA that handled ventilators tried to figure out how to work with the branch of the FDA that handled oxygen concentrators.
The great thing about our arrangement with the NHS was we gave them the IP, so they owned the app. They were also the only people using the app (the have an effective monopoly on emergency medicine in the UK), so if something went wrong it's the NHS using an NHS app and they could work it out themselves, and not companies suing companies.
I don't think that kind of simple arrangement would be possible in the US, but I don't know much about US healthcare apart from it isn't nationalised.