Darmiyan’s BrainSee Receives FDA Approval for Post-Market Surveillance Study
SAN FRANCISCO, May 29, 2025 – Darmiyan, Inc., a leading brain health technology company, has announced that the U.S. Food and Drug Administration (FDA) has approved its post-market surveillance study for BrainSee, a groundbreaking clinical prognostic tool for Alzheimer’s disease. The 7-year study aims to further validate the safety and effectiveness of BrainSee in a socio-demographically diverse patient population across the United States.
BrainSee is an AI-powered technology that combines standard brain MRI, basic cognitive assessments, age, and biological sex to generate a prognostic score. It is the first and only FDA-approved, non-invasive technology that offers clinicians actionable insight into whether patients over 55 with amnestic mild cognitive impairment (aMCI) will progress to clinical Alzheimer’s disease within five years. The FDA granted BrainSee marketing authorization in January 2024 via the De Novo pathway.
Unlike traditional Alzheimer’s tests that detect non-specific biomarkers like amyloid beta plaques, BrainSee predicts disease progression. Roughly 40% of amyloid-positive aMCI patients remain stable for at least five years or return to normal cognition. These individuals are unlikely to benefit from anti-amyloid drugs and may face unnecessary side effects. BrainSee was developed to fill this critical gap by identifying those most likely to progress and guide them through the next steps aiming to prevent or delay the onset of dementia symptoms.
The post-market study will collect, curate, and analyze large-scale data from patients of diverse ethnic and socioeconomic backgrounds via community clinics and hospitals. It will also highlight BrainSee’s clinical utility in underrepresented populations. Darmiyan is collaborating with leading Alzheimer’s Disease Research Centers and nationally recognized datasets, including the National Alzheimer’s Coordinating Center (NACC) and the Alzheimer’s Disease Neuroimaging Initiative (ADNI).
“With FDA approval of our post-market study, we aim to demonstrate BrainSee’s value in addressing one of the most pressing challenges in medicine: equitable access to high-quality, predictive care that guides dementia prevention, improves outcomes, and reduces costs,” said Dr. Kaveh Vejdani, Chief Medical and Technology Officer of Darmiyan.
Darmiyan invites healthcare professionals, research collaborators, and advocates for health equity to join this mission to improve outcomes and reduce disparities in dementia diagnosis and care. The company is based in San Francisco and is revolutionizing brain health assessment with its flagship product, BrainSee, which leverages proprietary Virtual Microscope technology and advanced AI to provide non-invasive, highly accurate prognosis for patients at risk of Alzheimer’s disease.
