Half Of 24 FDA-Cleared Clinical AI Or Machine Learning Devices For Dementia Lack Training/Validation Data

Of 24 artificial intelligence (AI) or machine learning (ML) devices cleared by the FDA for clinical use with people with Alzheimer’s disease and related dementias (ADRD), 12 lacked information about the training or validation data sets, a recent analysis found.

In 2021, the FDA issued guiding principles encouraging demographic representativeness for AI and ML devices, and updated guidance issued in 2025 suggested requirements for demographic data reporting for AI and ML devices, or justification for missing data.

The researchers were unable to find information on training or validation datasets in FDA summaries or peer-reviewed articles for 12 of . . .