MedCity News April 13, 2021
In a review of 130 FDA-cleared AI tools, researchers found that the vast majority of them relied on retrospective studies. Most of the developers also didn’t share information on how many sites the algorithms had been tested in, or how they performed in different patient demographics.
The Food and Drug Administration is greenlighting AI tools at a faster pace, from computer vision tools to flag potential cases of pulmonary embolism from CT scans, to identifying early-stage lung cancer. But critical information is missing from the FDA clearance process that could measure of how these devices actually work in patient care.
A review of 130 FDA-cleared AI devices published in Nature found that almost all of them were based...
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