How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations
Abstract We reviewed 1016 FDA authorizations of AI/ML-enabled medical devices to develop a taxonomy capturing key variations in clinical and AI-related features. Quantitative image analysis remains the most common application, but its relative proportion has declined recently. Over 100 devices lever...
Saved in:
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-07-01
|
| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-025-01800-1 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849389321643098112 |
|---|---|
| author | Rohan Singh Monika Bapna Abdul Rahman Diab Emily S. Ruiz William Lotter |
| author_facet | Rohan Singh Monika Bapna Abdul Rahman Diab Emily S. Ruiz William Lotter |
| author_sort | Rohan Singh |
| collection | DOAJ |
| description | Abstract We reviewed 1016 FDA authorizations of AI/ML-enabled medical devices to develop a taxonomy capturing key variations in clinical and AI-related features. Quantitative image analysis remains the most common application, but its relative proportion has declined recently. Over 100 devices leverage AI for data generation, though none yet involve LLMs. Our taxonomy clarifies current AI usage in medical devices and provides a foundation for tracking developments as applications evolve. |
| format | Article |
| id | doaj-art-4b9f9db658d64c9582d07d1c18eb0593 |
| institution | Kabale University |
| issn | 2398-6352 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Digital Medicine |
| spelling | doaj-art-4b9f9db658d64c9582d07d1c18eb05932025-08-20T03:42:00ZengNature Portfolionpj Digital Medicine2398-63522025-07-01811610.1038/s41746-025-01800-1How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizationsRohan Singh0Monika Bapna1Abdul Rahman Diab2Emily S. Ruiz3William Lotter4Dana-Farber Cancer InstituteBrigham & Women’s HospitalDana-Farber Cancer InstituteBrigham & Women’s HospitalDana-Farber Cancer InstituteAbstract We reviewed 1016 FDA authorizations of AI/ML-enabled medical devices to develop a taxonomy capturing key variations in clinical and AI-related features. Quantitative image analysis remains the most common application, but its relative proportion has declined recently. Over 100 devices leverage AI for data generation, though none yet involve LLMs. Our taxonomy clarifies current AI usage in medical devices and provides a foundation for tracking developments as applications evolve.https://doi.org/10.1038/s41746-025-01800-1 |
| spellingShingle | Rohan Singh Monika Bapna Abdul Rahman Diab Emily S. Ruiz William Lotter How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations npj Digital Medicine |
| title | How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations |
| title_full | How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations |
| title_fullStr | How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations |
| title_full_unstemmed | How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations |
| title_short | How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizations |
| title_sort | how ai is used in fda authorized medical devices a taxonomy across 1 016 authorizations |
| url | https://doi.org/10.1038/s41746-025-01800-1 |
| work_keys_str_mv | AT rohansingh howaiisusedinfdaauthorizedmedicaldevicesataxonomyacross1016authorizations AT monikabapna howaiisusedinfdaauthorizedmedicaldevicesataxonomyacross1016authorizations AT abdulrahmandiab howaiisusedinfdaauthorizedmedicaldevicesataxonomyacross1016authorizations AT emilysruiz howaiisusedinfdaauthorizedmedicaldevicesataxonomyacross1016authorizations AT williamlotter howaiisusedinfdaauthorizedmedicaldevicesataxonomyacross1016authorizations |