A research team at the University of Toronto counted every artificial-intelligence medical device the American regulator has authorized for use on patients. There are one thousand three hundred and fifty-seven of them. Then they looked for evidence that any of those devices helps a patient live longer or better. They found three.

That gap is not a scandal, and understanding why is the whole episode: the clearance pathway asks about resemblance, not benefit. The same structure sits inside the AI certificate a vendor is about to put in front of you.

In this episode, Stephen Forte covers:

• The numbers from the device census: 1,357 AI medical devices authorized for patient care, 34 appearing in any registered clinical trial, 12 with posted results, and 3 tested against patient-centered outcomes such as mortality or hospitali ...