FDA Approves First AI-Based Memory Loss Prediction Software

The US Food and Drug Administration (FDA) has granted De Novo approval to Darmiyan, a San Francisco-based brain imaging analytics company, for its product BrainSee. This software platform uses clinical brain MRIs and cognitive tests to predict the likelihood of memory loss progression within the next five years. BrainSee’s automated system provides results on the same day the scans and cognitive test scores are entered, shifting the treatment of mild to early cognitive decline from biomarker-based methods to actionable forecasts. The FDA’s De Novo designation signifies that BrainSee has no clear market predecessors but has proven its effectiveness and safety in clinical trials. BrainSee received FDA breakthrough designation in 2021. The software assigns an objective score indicating the patient’s odds of memory deterioration within the following five years, potentially leading to early treatment and peace of mind for some individuals. The economic impact of BrainSee is expected to be significant, reducing the billions of dollars annually spent on Alzheimer’s care through more effective management and treatment.