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.