FDA-Cleared Gap

A review of every FDA-cleared AI medical device found three of 1,357 were tested against outcomes like death or readmission. Only twelve ever published a prospective trial at all. If you are buying AI on the strength of a certification, you are buying that same gap, and that holds in any industry. One limit worth carrying with the number: the count rests on registered trials and published papers, so evidence a manufacturer holds privately would not show up in it.