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Artificial Intelligence and Alzheimer's Disease: FDA Approves BrainSee AI for Cognitive Assessment

Brain with computer elements around it representing the AI in healthcare

The U.S. Food and Drug Administration (FDA) has granted de novo clearance to BrainSee, an artificial intelligence (AI) program developed by Darmiyan. This cutting-edge software analyzes standard brain MRI scans to predict the progression from mild cognitive impairment to Alzheimer's disease and dementia within five years.

Innovative Functionality with Artificial Intelligence for Alzheimer's Disease


Described as a virtual microscope, BrainSee offers a novel approach to brain health assessment. It can serve as a precursor to positron emission tomography (PET) scans, eliminating the need for radioactive tracer injections. Moreover, it provides a non-invasive alternative to invasive procedures like cerebrospinal fluid biopsies, streamlining cognitive health assessment.

Breakthrough Designation 

Having received a breakthrough designation from the FDA in 2021, BrainSee offers a quantitative scoring system ranging from 0 to 100. This enables healthcare professionals to categorize patients by risk and consider appropriate treatment options. The program requires only a standard 3D MRI scan, without contrast injections, and utilizes cognitive test scores from diagnostic workups.

Significance for Early Detection 

BrainSee's significance lies in its ability to enhance early detection and prediction of Alzheimer's disease, with implications for patient care. Its non-invasive nature aligns with patient-centric diagnostics, minimizing the need for invasive procedures and radioactive tracers.

Milestone Achievements 

Darmiyan's journey to FDA clearance includes a breakthrough designation in 2021 and funding from Y Combinator in 2017. A $6 million seed financing round in 2020, led by Eisai, further supported its innovative capabilities. With support from IT-Farm and Y Combinator, the industry recognizes Darmiyan's potential to advance brain health diagnostics.


As BrainSee receives FDA de novo clearance, it heralds a new era in AI-driven neurological assessments. By integrating AI into cognitive health evaluations, BrainSee offers a streamlined approach to predicting and managing cognitive health issues. Its approval underscores the intersection of AI and healthcare, showcasing the transformative potential of innovative technologies in disease diagnosis and patient care.


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