STAT+: After a lull, the pace of FDA authorization of AI-enabled medical devices is rising
The Food and Drug Administration on Thursday released a new accounting of artificial intelligence tools cleared for use in health care, adding scores of new products designed to reshape care in several areas of medicine.
The update included 171 new products that use artificial intelligence and machine learning, including 155 authorized since August of 2022. The agency’s data indicate that, after a lull during the Covid-19 pandemic, the number of authorized devices in 2023 is expected to increase by more than 30% over the prior year.
The list of AI devices was first published after a STAT investigation reported that the FDA had failed to keep the public informed on its regulation of AI devices, or crucial details on the tests undertaken to prove their safety and effectiveness. The summary documents that describe new AI devices often fail to break out the demographics of the patients they were tested on, or where the testing took place, which makes it difficult for clinicians and patients to understand their potential biases and weaknesses.
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