US-based brain technology company Darmiyan has received the US Food and Drug Administration (FDA) approval for its advanced clinical test, BrainSee.

BrainSee test is the first clinical application of Darmiyan’s patented core technology, which builds on more than 40 years of advanced brain science.

It is a fully automated software platform that combines standard clinical brain MRI and cognitive assessments to generate an objective score that predicts the likelihood of disease progression.

Based on whole-brain image analysis and medical AI, BrainSee will predict the progression from amnestic mild cognitive impairment (aMCI) to Alzheimer’s dementia, within five years.

BrainSee received FDA breakthrough designation in 2021, and the FDA approval marks a major advancement in brain health, said the brain health company.

Darmiyan founder and CEO Padideh Kamali-Zare said: “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.”

BrainSee offers early screening and risk stratification that enables timely and personalised treatments for those aMCI patients at high risk of progression to Alzheimer’s dementia.

It aims to delay the onset of dementia to reduce the need for costly and invasive tests and the heavy burdens of financial and emotional abuse.

The prognosis test shifts patient experience from prolonged anxiety to proactive management, which can help determine suitable treatment candidates for Alzheimer’s treatment.

BrainSee will also result in a positive economic impact by reducing the costs of Alzheimer’s care, through more effective management and treatment.

Furthermore, the test will deliver prognostic accuracy, patient convenience, same-day test results and seamless integration into the clinical workflow.