FDA has now cleared more than 500 healthcare AI algorithms

FDA has now cleared more than 500 healthcare AI algorithms

LF
Lewis Farrell
Feb 7, 2023
1 min read

According to the US Food and Drug Administration (FDA), as of January 2023, over 520 AI medical algorithms had been cleared in the US, with the majority of them being related to medical imaging. By analyzing vast amounts of data generated during healthcare delivery, AI and ML technologies have the potential to transform healthcare. Because of the high accuracy of AI pattern recognition, there has been a focus on medical imaging applications such as diagnostic aids, quantification, contouring, and clinical decision support. AI is also being used in non-clinical areas of healthcare, such as IT systems to sort through patient data and extract relevant information. Clinical AI requires regulatory approval from the FDA, whereas non-clinical AI does not. With the rapid growth of FDA-approved AI and ML systems, the number of AI medical algorithms is expected to grow in the future.

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Lewis Farrell

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