AI/ML-enabled medical technology products approved by FDA in the U.S. 2015-2023

Published by Statista Research Department, Nov 20, 2024

In 2023, it was forecast the number of FDA approvals for AI/ML-enabled medical technology innovations would reach 185. Starting only at five approvals in 2015, the number of innovations involving AI/ML that annually got approved by the FDA grew rapidly throughout the following years, reaching more than one hundred by 2020.

Annual number of AI/ML-enabled medical technology products approved by FDA in the Unted States from 2015 to 2023

CharacteristicNumber of approvals
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Showing entries 1 to 9 (9 entries in total)
Statistic: Annual number of AI/ML-enabled medical technology products approved by FDA in the Unted States from 2015 to 2023

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Release date

February 2024

Region

United States

Survey time period

2015 to 2023

Supplementary notes

* Projected

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