It is to be made in the UK and not available there either. But yes, if it is to be FDA approved it will take years to slog through the process and opposition by test strip blood drop device makers. Diabetes, especially Type II, is HUGE business. Ever wonder who sponsors research that causes the clinical norms to keep falling for Diabetes and High Blood Pressure?
If I make a device that tests for Diabetes and High Blood Pressure, I gotta make sure that there’s lots of Diabetes and High Blood Pressure..................
Just like:
If I have a political party that depends on votes from poor and uneducated people, I gotta make sure that there’s lots of poor and uneducated people..................