Brain health solutions company Darmiyan received FDA approval of its BrainSee clinical test, a highly-scalable and fully-automated software platform that combines standard clinical brain MRI and cognitive assessments and generates a score that predicts the likelihood of progression from aMCI to Alzheimer’s dementia within five years. 

BrainSee is the first clinical application of Darmiyan’s patented core proprietary technology that is based on more than 40 years of brain science research, powered by advanced whole-brain image analysis and medical AI, the company says.

“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,” says Padideh Kamali-Zare, PhD, founder and CEO of Darmiyan.

Capabilities of BrainSee

Early screening and risk stratification by BrainSee enables timely and personalized treatments for those aMCI patients at high risk of progression to Alzheimer’s dementia, aiming to delay dementia onset, while reassuring those at lower risk of progression, hence reducing the need for costly and invasive tests and the heavy burdens of financial and emotional abuse. This shifts the patient experience to proactive management, which is crucial in an era of emerging Alzheimer’s treatments where accurate prognosis can help determine suitable treatment candidates.

BrainSee was previously granted FDA breakthrough designation in 2021. It was designed for prognostic accuracy, patient convenience, same-day test results, and seamless integration into the clinical workflow. Global availability of MRI significantly enhances BrainSee’s clinical utility. 

Most notably, BrainSee shifts the paradigm in aMCI workup from biomarker-based methods that have limited real-world capabilities due to their invasiveness, non-specificity, cost, and inaccessibility, to non-invasive and actionable forecasts of future improvement or progression.