FDA Approves AI Tool for Predicting Cognitive Decline: Transforming Early Diagnosis and Care

The US government has granted approval for AI-driven memory loss prediction software for the first time. Darmiyan, a San Francisco-based brain imaging analytics firm, has received FDA De Novo approval for its product, BrainSee. This software platform generates an objective score that predicts the likelihood of progression from mild cognitive impairment (aMCI) to Alzheimer’s dementia within five years.

BrainSee utilizes standard clinical brain MRIs and cognitive assessments to predict memory loss progression. After analyzing these evaluations, the software assigns a predictive score that indicates a patient's risk of memory deterioration in the next five years. This innovation aims to facilitate early treatment for some patients and provide peace of mind for others.

The introduction of BrainSee transforms the patient experience from enduring prolonged anxiety to proactive management. This is particularly vital as new Alzheimer’s treatments emerge, where accurate prognostic information can help identify suitable candidates for therapy.According to Darmiyan, the economic implications of BrainSee are substantial, potentially reducing the billions spent annually on Alzheimer’s care through improved management and treatment strategies.

The FDA’s De Novo designation indicates that BrainSee is a novel product, lacking direct market predecessors, yet demonstrating efficacy and safety in clinical trials. The software first earned FDA breakthrough designation in 2021, marking an important step in its approval process.

BrainSee offers fully automated results within the same day of inputting the scans and cognitive test scores, shifting the focus from traditional biomarker-based evaluations to non-invasive, actionable predictions regarding cognitive decline.