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Annual trends in FDA approvals for AI-enabled medical devices and software for children (2015–2023)
| Year | Number of FDA approvals for AI/ML-enabled medical devices | Licensed for children (percentage relative to total FDA approvals %) |
|---|---|---|
| 2015 | 5 | 1 (20.0) |
| 2016 | 19 | 0 (0.0) |
| 2017 | 26 | 1 (3.8) |
| 2018 | 63 | 7 (11.1) |
| 2019 | 76 | 4 (5.3) |
| 2020 | 108 | 13 (12.0) |
| 2021 | 123 | 10 (8.1) |
| 2022 | 139 | 24 (17.3) |
| 2023 | 108 | 9 (8.3) |
