Posted 1/12/2024, 6:50:34 PM
FDA Approves First AI Software to Predict Alzheimer's Disease Progression
- The FDA has approved Darmiyan's BrainSee software, which predicts likelihood of cognitive decline progression in the next 5 years
- BrainSee analyzes brain MRIs and cognitive tests to assign a predictive score for Alzheimer's disease risk
- It is the first FDA-approved AI product to predict cognitive decline/Alzheimer's progression
- Approval is under "De Novo" designation for novel devices with proven safety and effectiveness
- BrainSee aims to enable early Alzheimer's treatment and reduce healthcare costs through effective management