BrainSee
FDA-approved AI software for predicting Alzheimer's progression from mild cognitive impairment
Company profile
Company profile
Darmiyan is a medical AI company focused on revolutionizing brain health diagnostics through advanced imaging analysis. The company's name, a Persian word meaning 'in-between,' reflects its focus on the space between brain cells and the critical period between normal health and neurodegenerative disease. Founded by a team of neuroscientists, data scientists, healthcare experts, and patient advocates, Darmiyan leverages over 40 years of cutting-edge neuroscience research combined with advanced medical image processing and machine learning to address early detection of neurodegenerative diseases. The company's patented core technology, DarmiScope, functions as the first virtual microscope of the human brain, offering unprecedented precision in quantifying cellular-level changes within every voxel (3D pixel) of a brain MRI scan. Their flagship product, BrainSee, received FDA De Novo approval in January 2024 and is the first FDA-approved medical software designed to help physicians evaluate the prognosis of patients diagnosed with amnestic mild cognitive impairment (aMCI). BrainSee combines a patient's brain MRI with cognitive test scores to generate a score between 0 and 100, helping doctors determine the likelihood of progression to Alzheimer's dementia with approximately 90% accuracy over a 5-year period. Darmiyan serves healthcare providers, pharmaceutical companies, and clinical researchers working to advance brain health and wellness. The company aims to provide an à la carte menu of brain tests developed with four pillars of excellence: high accuracy, non-invasiveness, seamless integration, and high accessibility worldwide. Their technology has been validated through blind testing of 411 cases with 5-year follow-up and by independent third-party investigators in the US and Canada.
Company description Darmiyan official website
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01 · Operating footprint
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Cloud Saas · Other deployment with recorded integration context.
Company milestones
FDA De Novo approval for BrainSee (January 2024). FDA Breakthrough Device Designation (May 2021). Validation by third-party investigators (2020). $6M funding round led by Eisai (2020).
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02 · Flagship portfolio
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FDA-approved AI software for predicting Alzheimer's progression from mild cognitive impairment
The first Virtual Microscope of the human brain resolving tissue structure in every voxel of brain MRI
03 · Research intelligence
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Research
Neurochemical research · Jan 1, 2020
Clinical validation
No linked records are currently available.
Regulatory
DEN220066 · De Novo · Jan 11, 2024
04 · Company-reported outcomes
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predicting 5-year clinical prognosis of MCI
can be applied to any clinical grade MRI
Proof of concept study focused on early detection of Alzheimer's disease at preclinical (presymptomatic) stage
Partnership through CABHI for clinical validation and innovation testing
Partnership through CABHI for clinical validation and testing
Partnership for clinical validation and testing of BrainSee technology
Clinical validation and neuroradiology partnership for BrainSee technology
05 · Leadership
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06 · Company updates
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08 · Official presence
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09 · Market pathway
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Market context
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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