3 of 1,357 Cleared AI Devices Have Public Outcome Trials. The Study Has No Non-AI Comparator.
The census counts publicly registered evidence, so it measures disclosure. Without a non-AI comparator it cannot show this is an AI problem.
510(K) Clearence
Two FDA Device Authorisations, Two Sets of Evidence Narrower Than the Headline
Aletta matches human phlebotomists only when it agrees to attempt a draw. Narwhal cleared on bench and animal data, citing a trial with a different probe.
A Third Centiloid Scale Just Cleared. The First Two Already Disagree at the Threshold.
Cortechs.ai clears NeuroQuant PET for Centiloid amyloid quantification, entering a field where the two incumbent scales differ by more than 10 Centiloids.