GROWING USE OF AI AND MACHINE LEARNING IN MEDICAL DEVICES

The Food and Drug Administration estimates it’s authorized at least 300 AI or machine learning-enabled medical devices for marketing since 2010. Not all AI algorithms used in clinical care require FDA clearance.
Estimated number of AI/ML-enabled devices authorized per year | The chart below is interactive: click or touch to see more.

[Chart]

Notes

* Through June 17
For devices with multiple submissions, the first date of approval was used.

Source: Food and Drug Administration

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