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BioImaginix is developing a low-cost, definitive diagnostic tool for Alzheimer's disease (AD) and mild cognitive impairment (MCI) using only MRI scans and a generative AI-based algorithm (accuracy: AD versus MCI 81.41% and autopsy-confirmed AD vs. MCI 92.75%). The proof-of-concept is published in a peer-reviewed AD-specialized journal. The product has three most important aspects: the algorithm is tested in autopsy-validated AD cases, validated in two different patient cohorts, and overcoming the data leakage problem. Neurologists/Gerontologists will use it for diagnostic purposes and patient stratification in clinical trials. The technology would overlay MRI retrieval and provide an additional interpretive and diagnostic aspect to help neurologists give a more accurate diagnosis of AD, MCI, and normal brain. We aim to validate by testing differential diagnosis of AD vs. other non-AD dementia patients and finally submit to the FDA for approval as Software as a Medical Device through the 510(k).