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Artificial Intelligence in Diagnosis and Management of Alzheimer's Disease and Related Dementias: Evaluation of FDA Device Regulation
0
Zitationen
6
Autoren
2025
Jahr
Abstract
We found that the availability of evidence supporting FDA-cleared AI/ML-based devices for ADRD, including training and validation datasets and demographic characteristics of patients involved in algorithm development, was limited. These gaps limit clinicians' ability to make informed decisions when using these devices, raising concerns of unintended outcomes for patients living with ADRD, particularly racial/ethnic minorities.
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