[NationalPark]

What are the devices you have in mind? It doesn't seem like the intersection between "people with biomedical engineering skills" and "people who need treatment limited by the expense of the equipment" would be that large. I suppose I can imagine a sort of shadow economy of cheap medical treatment on home-built equipment, but surely the providers would be uninsurable and sued into oblivion at the first mistake.

[guelo]

Ones that immediately comes to my mind are ultrasound,and hearing aids. If they were unregulated there would be cheap OTC devices available.

[complexworld]

I work on a handheld ultrasound device that attached to a phone or a tablet. It is much easier to use than traditional ultrasound machines, because of the attention paid to the UX off the app, and the familiar smartphone UI.

That being said I will haven't learned how to use it in a meaningful way myself. Getting a good image, and then interpreting the 2d video stream requires training!

Making ultrasound easy enough for non specialists to use will require an AI that guides the user and interprets the images. I'm not convinced skipping FDA approval would be a good idea in this case.

[j-bos]

At least in the US, there's a fair amount of immigrant medical professionals who have the training, often the experience, but not the licensing.

[dijonman2]

What’s getting in the way of their american licensing ?

[j-bos]

If they didn't finish their school their studies are often regulatorily worthless in the US, if they did there's still massive hurdles to jump without existing relationships/wealth to aid the transition.

[labcomputer]

The AMA.

[guelo]

Why can't ultrasounds produce 3D?

[newaccount74]

They can, but since the data is very noisy the 3D reconstruction is usually not very good.

If you actually need to measure something, analysing the 2D images is much more precise.

EDIT: Also, it's really hard to visualise density in a 3D view.

[guelo]

I just don't see what harm there is in making unregulated devices even if they're hard to interpret and less acurate.

[newaccount74]

The problem with 3D reconstruction being difficult has nothing to do with wether devices are regulated ornot.

Also,noone is stopping you from making a DIY ultrasound and selling it to enthusiasts.

[roywiggins]

OTC hearing aids may actually be happening:

https://www.fda.gov/news-events/press-announcements/fda-issu...