
Darmiyan Receives FDA Approval for Post-Market Surveillance Study of BrainSee, the First-in-Class Clinical Test for Predicting Risk of Progression to Clinical Alzheimer’s Disease
SAN FRANCISCO, May 29, 2025 /PRNewswire/ — Darmiyan, Inc., a leading brain health technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s post-market surveillance study for BrainSee, its groundbreaking clinical prognostic tool for Alzheimer’s disease. This 7-year study aims to further validate the safety and effectiveness of BrainSee in a socio-demographically diverse patient population across the United States. The insights gained will also support pharmaceutical companies and contract research organizations (CROs) in identifying optimal candidates for next-generation Alzheimer’s clinical trials—advancing both precision and equity in patient selection.