Getting government/insurance approval for medical device

Hey everybody, so I been working on this concept for a portable device that would help blind people navigate around, huge upgrade over using a cane.

Thing is that it wont be cheap, not super-expensive like those OCR-to-voice Kurzweil devices back in the day but the price might keep it away from people who could really use something like this.

What I need to know is how its the process to get it FDA-certified (and equivalents for other countries/areas like Europe and Japan) so insurance companies and/or governments could provide them to users like they provide powered wheelchairs and other devices for the disabled.

Thanks