The medical specialty that saw the earliest FDA approval of an AI diagnostic tool is Radiology. This approval marked a pivotal milestone in the adoption of medical AI technologies. The first FDA approval for an AI/ML-based medical device was granted in 2016, specifically in the field of Radiology, which has since become a leader in the introduction of AI technologies for image reading and diagnostics[8].
As of the end of 2020, there were 64 AI/ML-based medical devices and algorithms approved by the FDA, with the majority, 30 devices (46.9%), being developed for Radiology, underlining its prominence in this area of innovation[8].
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