Research finds insufficient data transparency for FDA-cleared AI devices in Alzheimer’s imaging, raising bias and generalizability concerns.
Key Details
- 124 AI/ML-based devices for Alzheimer's disease and related dementias (ADRD) were FDA-authorized between January 2015 and December 2024.
- 291.7% (22/24) were cleared via the 510(k) pathway; 8.3% (2/24) through de novo classification.
- 3For 12 devices, there was no info on training or validation data in FDA summaries or peer-reviewed articles.
- 4Only 2 FDA summaries (8.3%) included external validation data; 10 peer-reviewed articles (41.7%) provided such data.
- 5Reporting of disease status, age, sex, race, and ethnicity was rare across most devices; demographic transparency was lacking.
- 6Most devices (21) were reviewed by radiology panels and primarily involved MRI and PET imaging.
Why It Matters

Source
AuntMinnie
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