Darmiyan Receives FDA Approval for BrainSee to Test for Alzheimer’s Dementia

Darmiyan has received the U.S. FDA clearance for BrainSee, a medical software designed to help physicians determine the prognosis of patients with amnestic mild cognitive impairment (aMCI), marking a significant advancement in brain health and opening the door to untapped market potential in the diagnosis and management of brain disorders.

Based on Darmiyan‘s proprietary core technology in brain science, advanced whole brain image analysis, and medical AI, BrainSee is a highly scalable and fully automated software platform that combines standard clinical brain MRI and cognitive assessments, to generate an objective score that predicts the likelihood of progression from aMCI to Alzheimer’s dementia within 5 years.

Early screening and risk stratification by BrainSee enables timely and personalized treatment for those aMCI patients at high risk of progression to Alzheimer’s dementia, with the aim of delaying the onset of dementia, while reassuring those at lower risk of progression. This shifts the patient experience from prolonged anxiety to proactive management, which is critical in an era of emerging Alzheimer’s treatments where accurate prognosis can help identify suitable treatment candidates.

BrainSee addresses a critical unmet need for over 10 million Americans and over 100 million patients worldwide living with aMCI. With an ageing global population, the socio-economic impact of BrainSee is expected to grow rapidly and exponentially.

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