The situation in the US is insane. Yes there are systems, like radiotherapy machines or pacemakers, that need to be developed and tested to Nasa like specs But

The situation in the US is insane. Yes there are systems, like radiotherapy machines or pacemakers, that need to be developed and tested to Nasa like specs But the FDA take the approach that anything medical is life threatening. It's as if the FAA demanded avionics approval for the point of sale machine in the McDonalds at the airport You cannot use a camera on a microscope in the US for medical purposes, there is no approval and there won't be because the first company to do so has to prove beyond all doubt every concept of the camera, computer and display operation. Not just of their specific device - you have to prove that a camera is equivalent to an eye in basic principles. Then once you have done that every other maker can come on your coat tales. That's why in europe your cervical smear test will go through an automated scanner which uses state of the art image processing to examine every single cell - and quickly enough that the entire population (or at least the half with a cervix) can be screened. In the US it will be looked at for 5mins with 50year old eyes with a 30year old microscope by a doctor who will then guess (sorry use his years of experience) to decide. Strange really - I don't imagine the FAA would accept an aircraft maker saying that they don't use CFD tools or computers but old Billy has a certificate saying he went to engineering school and so can estimate the load in a carbon fibre turbine blade by eye.