Welcome to modern medicine. Starting with the Reagan administration, oversight over medical devices has been greatly reduced. You have a lot of leeway with medical devices, even moreso than with drugs.

Lots of billion dollar medical companies have leading politicians on their board. Donald Rumsfeld was on the board for Gilead Sciences. It is vital for these businesses that to be on good terms with the government, as it is the government helps define what is allowed.

Some would argue that this is just a form of corruption which endangers the lives of patients worldwide.