Before a medical device is sold, it has to go through a whole series of approvals and regulations. Does it resemble a pre-existing device? Is this the first of its kind? What kind of risk does its misuse/misapplication put its patient at?
All of these questions help decide which approval pathway the device will go through, and because of that, how long it will take the device to be approved and appear on the market. Artificial intelligence/machine learning (AI/ML) medical devices are no different.
In recent years, AI/ML has been used in several medical devices/procedures.