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.

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 the age of 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. Any licensed physician, not just neurologists, can prescribe the test. This includes primary care providers such as internists and family medicine doctors, as well as specialists in psychiatry, geriatrics, and preventive medicine. This broad accessibility is a major differentiator, enabling early cognitive risk assessment at the point of first contact—often in primary care settings—without the need for specialist referral.

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), the Health & Aging Brain Study – Health Disparities (HABS-HD), the Alzheimer's Disease Neuroimaging Initiative (ADNI), the University of Alabama at Birmingham (UAB) ADRC, UC Davis ADRC, and the Open Access Series of Imaging Studies (OASIS) of Washington University.

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.

"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. "We're proud to work with these national leaders to ensure no community is left behind in the fight against Alzheimer's disease."

About Darmiyan, Inc: Based in San Francisco, Darmiyan is a neuroscience and AI company revolutionizing brain health assessment. Its flagship product, BrainSee, leverages proprietary Virtual Microscope technology and advanced AI to provide non-invasive, highly accurate prognosis for patients at risk of Alzheimer's disease.

More info: darmiyan.com | brainsee.ai

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