IAAD and I work in this area.
ISO 13485 has very specific standards for any medical device that touches patients.
To get an ISO 13485 + ISO 27001 (data security) rated product with software is going to take $500k to get to the stage where you can pilot and go for second round funding.
I have found that it is easy to show that a product works in optimum conditions e.g. with people who will stay still and not move about, but put a lot of these technologies into real life situations and the data they output is landfill quality.
This is one of the really annoying things - we have politicians who think that Joe average is going to upload the data from their heart monitor and we are going to stop him going to the Emergency Department.
The diagnosis I make is only as good as the data I base that on. That is why Apple has pulled all its apps with medical claims. The consequences of misdiagnosis due to poor data mean a PR disaster on the scale of Volkswagen diesels.
I am not saying that some of this stuff is impossible, but don't expect too much too soon, and if the device and software are not certified, I cannot use them in my practice so they are just shiny paperweights.