Daniel Schultz, the FDA's chief device regulator, says new medical devices don't need the large-scale exhaustive trials of the drug industry because it is easier to predict the behavior of a machine than it is to track the chemical interactions of a new drug in the body.
Machine learning distills the raw information about the behavior of each individual customer and creates associations that are accurate, but general enough that a campaign based on those associations has a good chance of success with a substantial group of people.