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. 2025 Jul 30:e2512779.
doi: 10.1001/jama.2025.12779. Online ahead of print.

Demographic Data Supporting FDA Authorization of AI Devices for Alzheimer Disease and Related Dementias

Krista Y Chen  1 , Joseph S Ross  2   3 , Adam B Cohen  4   5 , Jason Karlawish  6 , Esther S Oh  7 , Ravi Gupta  1
Affiliations

Demographic Data Supporting FDA Authorization of AI Devices for Alzheimer Disease and Related Dementias

Krista Y Chen et al. JAMA. .
No abstract available

Plain language summary

This cohort study examines the availability and representativeness of data supporting US Food and Drug Administration–authorized artificial intelligence and machine learning devices to treat Alzheimer disease and related dementias.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Ross reported receiving grants from the US Food and Drug Administration, Johnson & Johnson, Medical Device Innovation Consortium, Agency for Healthcare Research and Quality, National Institutes of Health’s National Heart, Lung, and Blood Institute, and Arnold Ventures outside the submitted work; and served as an expert witness at the request of relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in September 2022. Dr Karlawish reported receiving personal fees from Linus Health for serving on the professional advisory board outside the submitted work. Dr Gupta reported receiving personal fees from Alosa Health and Sunday Health outside the submitted work. No other disclosures were reported.

References

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