I doubt the FDA will let this live too long. They regulate the medical industry and I'm fairly certain that any device that is placed in direct contact with a patient needs to be approved and certified (by the FDA) for use by a doctor.

I am by no means an expert, but there are several large companies (one of which I used to work for) that had prototypes like this for quite a while that couldn't go anywhere because they had to have FDA audit protection (lots. of. documentation.). Hopefully small medical startups like this have figured out a way around these problems while maintaining patient safety.