Utilizing brain MRI and cognitive assessments, the newly FDA-approved, AI-powered software platform BrainSee can reportedly predict the progression of amnestic mild cognitive impairment (aMCI) to Alzheimer’s dementia within five years.
The Food and Drug Administration (FDA) has granted De Novo approval for BrainSee, a software platform that may predict up to a five-year progression of amnestic mild cognitive impairment (aMCI) to Alzheimer’s dementia, based on a combined artificial intelligence (AI) assessment of brain MRI and cognitive assessments.
Through the aforementioned combination, BrainSee generates an automated score that notes the likelihood of progression from aMCI to Alzheimer’s dementia, according to Darmiyan, Inc., the developer of the software platform.
Darmiyan emphasized that for patients with aMCI deemed to be at high risk for developing Alzheimer’s dementia within five years, the predictive screening capability afforded by BrainSee may facilitate personalized treatment. For those deemed to be at lower risk of Alzheimer’s dementia progression, the non-invasive BrainSee risk stratification may decrease patient anxiety as well as costs of more invasive tests, according to Darmiyan.
"Our vision is to redefine brain health screening and monitoring standards and impact the lives of patients and their family members in a meaningful way,” noted Padideh Kamali-Zare, Ph.D., the founder and CEO of Darmiyan. “BrainSee is the first product of this vision, backed by our solid technological infrastructure that is capable of driving further transformations and scalable innovations in the brain health landscape.”
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