Darmiyan Gets De Novo OK for Test to Predict Progression to Alzheimer’s Dementia

Darmiyan has earned U.S. Food and Drug Administration (FDA) de novo approval for its BrainSee clinical test, which predicts progression from amnestic mild cognitive impairment (aMCI) to Alzheimer’s dementia.
 
BrainSee is the first clinical application for Darmiyan’s core technology, which is powered by advanced whole-brain image analysis and medical artificial intelligence (AI). The software platform combines standard clinical MRI and cognitive assessments and generates an objective score that predicts the chance of progression from aMCI to Alzheimer’s dementia within five years.
 
The early screening and risk stratification by BrainSee aims to delay dementia onset as well as reassure patients at lower risk of progression to reduce the need for costly and invasive tests and heavy burdens of financial and emotional abuse, the company said. This transforms the patient’s experience from prolonged anxiety to proactive management.
 
BrainSee was granted FDA breakthrough status in 2021. The company said it stands out for its prognostic accuracy, convenience, same-day test results, and integration into clinical workflow. BrainSee can shift the paradigm in aMCI workup from biomarker-based methods with limited real-world capabilities to non-invasive, actionable forecasts for future improvement or progression.
 
“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. 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,” said Dr. Padideh Kamali-Zare, founder and CEO of Darmiyan.