Darmiyan's BrainSee Receives FDA Green Light for Alzheimer's Risk Assessment Study

Darmiyan's Groundbreaking FDA Approval for BrainSee Study

In a significant advancement for Alzheimer's disease research, Darmiyan, Inc., a pioneering brain health technology company, has received approval from the U.S. Food and Drug Administration (FDA) for its post-market surveillance study on BrainSee, a revolutionary prognostic tool for Alzheimer's disease. This groundbreaking study will span seven years and intends to validate BrainSee's safety and effectiveness among a diverse group of patients across the United States.

What is BrainSee?

BrainSee is an innovative clinical test that utilizes AI technology combined with standard brain MRI, basic cognitive assessments, patient age, and biological sex to provide clinicians with a prognostic score. It is recognized as the first and only FDA-approved, non-invasive test that offers actionable insight into whether patients aged 55 and older with amnestic mild cognitive impairment (aMCI) are likely to progress to clinical Alzheimer's disease within five years. The FDA previously granted BrainSee marketing authorization in January 2024 via the De Novo pathway, making it a leading choice among existing Alzheimer's diagnostic tools.

Understanding the Need for BrainSee

Traditional Alzheimer's assessments often rely on detecting non-specific biomarkers such as amyloid beta plaques; however, not all patients with these biomarkers will develop the disease. Research indicates that approximately 40% of patients who test positive for amyloid continue to exhibit stable cognitive functioning for five years or even revert to normal cognitive status. These patients, classified as unlikely to benefit from anti-amyloid medications, may risk experiencing unnecessary side effects from such treatments.

In response to this critical gap, BrainSee aims to pinpoint patients most likely to progress towards Alzheimer's, guiding them toward preventive measures and better-informed healthcare decisions. Importantly, this tool broadens accessibility, allowing any licensed physician, from family doctors to specialists in geriatrics and psychiatry, to prescribe the test. This capability enhances the opportunity for early cognitive risk assessments at primary care visits, often before a patient needs a referral to an expert.

The Post-Market Study: Goals and Impact

Darmiyan's FDA-approved post-market study will focus on the collection, curation, and analysis of extensive data from patients representing various ethnic and socioeconomic backgrounds through community clinics and hospitals. The goal is to highlight BrainSee's clinical efficacy in underrepresented populations, ensuring equitable access to diagnostic tools for Alzheimer's. By collaborating with numerous esteemed research centers such as the National Alzheimer's Coordinating Center (NACC) and the Alzheimer's Disease Neuroimaging Initiative (ADNI), Darmiyan commits to implementing a comprehensive examination of BrainSee's applicability across different demographics.

As stated by Dr. Kaveh Vejdani, Chief Medical and Technology Officer at Darmiyan, "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." This collaborative effort also invites healthcare professionals, research associates, and health equity advocates to join the mission to improve dementia diagnosis and care.

The Future of Alzheimer's Diagnostics

Darmiyan, based in San Francisco, is determined to reshape brain health assessments using its proprietary Virtual Microscope technology coupled with advanced AI capabilities. BrainSee's groundbreaking approach allows for precise risk evaluations, leading the way toward a future where early intervention becomes the norm in Alzheimer's patient care. As healthcare evolves, Darmiyan’s commitment to innovation stands out, providing hope for better management of Alzheimer’s disease through effective risk stratification and intervention planning.

For further information, you can visit their official sites, darmiyan.com and brainsee.ai.