Guys think about it. The FDA sees this as a drug/ appliance combination. Reference the last CRL.....

There is no way the bureaucrats miss an opportunity to tax what might turn out to be the drug which slows the progression of the disease. I just pray this drug turns out to be one of the winners this tyrannical government chooses to support since it has the potential to reduce huge medical expenses by limiting hypoglycemic incidences.

If you can't beat them, join them.

Swing